Surgical Manual

CSR-DAT

The Implants 4 Clinical indications for the application of implant-prosthetic therapies 4 Side and secondary effects 5 General indications 6 Method of use 7 CSR-DAT implants 8 ZirTi surface 10 Table of colour codes 11

The range 12 CSR-DAT implants 12

Surgical instruments 14 Surgical kit 14 CSR-DAT Kit 16 General indications 18 Drills 19 Precision drill FS-230 20 Pilot drill CSR-FP-200 20 Intermediate drill CSR-FI-280 21 Final drills 23 Countersink drill 25 Drills for distal sectors 26 27 Easy Insert drivers 28 Drivers 30 Drivers for surgical cover screws and fixation screws 30 Torque wrench with control lever TWL 33 Torque control ratchet CRI5-KIT 34 Adaptors and extensions 36 Parallelism pins PP-2/28 37 Parallelism pins with laser-etched notches 37 Depth gauge PROF3 38 X-ray templates 38 Cleaning, disinfection, sterilization and storage of the kit and of the surgical instruments 39

Surgical sequences 44 Preparation of the implant site 44 Surgical sequences 44

General 50 Implant insertion 50 Intraoperative removal of implants if necessary 52 Maintenance of the prosthesis 52 Responsibility for defective products and warranty terms 52 Disposal 52 Composition of the materials 53 Identification of the manufacturer 54

Bibliography on Sweden & Martina implants since 2013 57 THE IMPLANTS

Clinical indications for the application of implant-prosthetic therapies

When assessing the patient, in addition to his/her eligibility as regards implant-prosthetic rehabilitation, it is usually necessary to consider the contraindications applicable to oral surgery procedures in general.

These include:

• clotting disorders, anticoagulant therapies; • healing or bone regeneration disorders; • decompensated diabetes mellitus; • metabolic or systemic diseases that compromise tissue regeneration with a particular influence on healing and bone regeneration; • alcohol abuse, smoking and use of drugs; • immunosuppressive therapies, such as: chemotherapy and radiotherapy; • infections and inflammations, such as periodontitis and gingivitis; • poor ; • inadequate motivation; • occlusion and/or articulation disorders as well as inadequate interocclusal space; • inadequate alveolar process.

It is contraindicated to insert implants and perform implant restorations in patients with poor general or oral health, those who are unable to monitor their general conditions properly or those who have had organ transplants. Psychologically unstable patients, alcohol or drug abusers, and poorly motivated or uncooperative patients should also be considered unsuitable for this kind of treatment. Patients with poor periodontal health should be treated first and allowed to recover. In the presence of a lack of bone substance or poor quality of the receiving bone, such as to compromise the stability of the implant, suitable guided tissue regeneration must be performed prior to implant treatment.

Contraindications also include: allergy to titanium (rare but documented in international literature), acute or chronic infectious diseases, sub-acute chronic maxillary osteitis, systemic diseases, endocrine disorders, diseases resulting in microvascular disorders, pregnancy, breastfeeding, previous exposure to radiation, haemophilia, granulocytopenia, steroids use, diabetes mellitus, kidney failure and fibrous dysplasia. The normal contraindications common to all oral surgery must also be observed. Surgery is not recommended for patients on anti- coagulant, anticonvulsant and immunosuppressant therapies, with active inflammatory-infective processes of the oral cavity, and patients with BUN and creatinine values outside the norm. Patients with cardiovascular disease, hypertension, thyroid or parathyroid diseases, malignant tumours found in the 5 years preceding the operation, or nodular swellings must also be rejected.

Chemotherapies reduce or eliminate the capacity for , therefore patients undergoing these treatments must be carefully screened before being rehabilitated with oral implantoprostheses. Numerous cases of bisphosphonate-associated peri-implant osteonecrosis of the mandible have been reported in literature. This problem particularly applies to patients treated intravenously. As a post-operative precaution, the patient must avoid any kind of strenuous physical activity.

4 THE IMPLANTS

Side and secondary effects

Situations that may occur after surgical procedures include temporary local swelling, oedema, haematoma, temporary sensitivity alterations, temporary masticatory limitations and post-surgical micro-haemorrhages in the following 12–24 hours. The patient may also experience pain, speech problems, gingivitis, loss of bone crest, permanent paresthesia, dysesthesia, local or systemic infections, exfoliation, hyperplasia, perforation of the Schneider membrane, oroantral and oronasal fistulas, perforation of the labial or lingual plate, bone fractures, implant fractures, fractures of over-structures, aesthetic problems, unnoticed perforation of the nasal sinus, nerve injuries, impairment of natural dentition. The following pathophysiological problems can increase the risks: cardiovascular failure, coronary disease, arrhythmia, pulmonary or chronic respiratory disease, gastrointestinal disease, hepatitis, inflammatory bowel disease, chronic kidney failure and disorders of the urinary system, endocrine disorders, diabetes, thyroid diseases, hematologic disorders, anaemia, leukaemia, coagulation problems, osteoporosis or musculoskeletal arthritis, stroke, neurological disorders, mental retardation, paralysis.

Before proceeding, it is important to perform a careful pre-operative analysis of the patient medical history to verify his or her suitability for the implant treatment. It is also recommended to collect and file all the clinical, radiological and radiographic records. After making models of the two arches, the best position and orientation of the chosen implants will be evaluated based on the occlusal plane and on the correct distribution of the forces. In this phase, a surgical stent may be created to guide the specialist to correctly position the implants during the operation. Depending on the specific case, a decision will be made on whether to use a single or double phase surgical procedure, using titanium cylinders (code DIM) to make the radiological/surgical stent.

A radiological and surgical stent can be made by using the special cylinders in titanium (code DIM), which can be used to obtain an ideal positioning of the implants in terms of biomechanics and aesthetics.

In addition to an oral examination, both clinical and with X-rays, it is recommended to take a T.C. scan of the interested area; once the X-rays and scans have been obtained, the specialist can identify the most suitable implant with the help of convenient transparent radiographic guides. The pre-operative study of the T.C. Dentalscan allows identifying the type of bone present in the insertion point of the implant. The choice of the surgical procedure must take into consideration the type of bone present. The bone is normally classified into 4 types according to the density. The classification (according to Karl Misch) is the following:

D1 BONE: all cortical bone. D2 BONE: a core of bone marrow enclosed in a shell of cortical bone.

D3 BONE: all bone marrow without D4 BONE: all bone marrow with a very cortical crest. poor level of mineralization.

Dentalscan images by kind permission of Dr. Marco Csonka - Catania - Italy 5 THE IMPLANTS

General indications

CSR-DAT fixtures are long-term implantable medical devices. All the fixtures are sold in single-use sterile packs. The function of the fixtures is to replace missing dental roots. The implants have a connection in the crown part for receiving a post aimed at supporting a dental prosthesis. In implant-prosthetic rehabilitation with CSR-DAT implants exclusively original prosthetic components by Sweden & Martina must be used. The use of non-original components limits the responsibility of Sweden & Martina S.p.A. and renders the product warranty void. The implants have a hybrid morphology, they are screw-shaped with an external thread and have a conical internal connection for connecting the prosthetic components. CSR-DAT implants can be inserted in both edentulous and post-extraction sites, either immediate (insertion of the implant at the same time as the removal of the tooth or root), or deferred (normally about 3 weeks between extraction and insertion of the implant fixture). All the fixtures are sold with the respective surgical cover screw. The surgical cover screws are also medical devices that can be implanted surgically, designed to remain in the oral cavity for even more than 30 days. The surgical cover screws can also be sold individually.

6 THE IMPLANTS

Method of use

The methods of use can be divided into two main surgical techniques: • Two stages: an initial “submerged” stage, with implant insertion, covering of the connection with a surgical cover screw, suturation and subsequent reopening of the mucous membrane 2–6 months later, followed by prosthesis insertion; • One stage: implant insertion and closure of the connection with a healing abutment instead of a surgical cover screw. Alternatively, in presence of suitable therapeutic indications, it can be loaded immediately with an appropriate temporary or permanent dental post, depending on the case.

Implants are inserted in the bone following surgical protocols that must be considered according to the quantity and quality of the receiving bone, the implant and any possible need for regenerative therapies. A site is created in the patient’s bone at the position of the new tooth to be replaced or inserted, using a series of calibrated bone drills or other suitable instruments, such as bone expanders, bone profilers or similar. The necessary conditions for the success of the implant are: • the presence of a certain quantity of bone; • good periodontal (gingival) support; • the absence of bruxism (tooth grinding) and serious malocclusions; • the presence of good occlusal balance (correct masticatory occlusal plane).

CSR-DAT implants have been tested in a wide range of clinical situations: • standard operating procedures; • immediate and early loading; • post-extraction situations, even combined with immediate loading.

Generally, masticatory loading with a fixed prosthesis occurs at a second stage, after 2 to 3 months for the mandible and after 4 to 6 months for the upper jaw. In some cases, but not all, immediate loading of the implants is possible; to do this it requires good primary stability, with no mobility or movement limited to a few microns. The bone-implant interface must therefore be of the order of a few millimicrons, otherwise there is the risk of fibrous integration for the implant.

The clinical indications for choosing the CSR-DAT implant depends on the site in which the implant is to be inserted, on the anatomy of the receiving bone, on the number of implants, and on the technique chosen from those mentioned above; the choice must be made exclusively by the doctor, who must have the suitable training and experience and must plan the prosthetic rehabilitations beforehand. Sweden & Martina S.p.A. has conducted 5.000.000 cycle fatigue resistance tests on CSR-DAT implants. The implants passed the test. Fatigue tests are conducted according to the standards and evaluated further with finite element calculations.

Key to CSR-DAT implant codes

Implants are coded with “mnemonic” codes that allow easy identification of the piece. Below is a table showing how the mnemonic codes work using VSR-ZT-420-115 as an example:

implant type surface diameter length VSR- ZT- 420- 115

VSR: CSR-DAT implants ZT: ZirTi surface 380: 3.80 mm 065: 6.50 mm 420: 4.20 mm 085: 8.50 mm 100: 10.00 mm 115: 11.50 mm 130: 13.00 mm 150: 15.00 mm 180: 18.00 mm

This is the dimension of the Nominal length expressing the endosseous diameter of the endosseous length of the implant. implant, measured at the medial third.

All measurements are in mm, unless otherwise indicated. 7 THE IMPLANTS

CSR-DAT implants

CSR-DAT implant presents innovative characteristics in the morphology and in the connection, together with a full treated ZirTi surface whose validity is documented by numerous in vivo, experimental and clinical studies. The implant is available in two diameters, 3.80 mm and 4.20 mm, and it simplifies the prosthodontist work, as it optimizes the stock, sincethe prosthetic components are in common to both the diameters.

CSR-DAT implants have have a hybrid morphology, designed to gain extreme primary stability, exploiting whenever possible the bicortical engagement. The shape of CSR-DAT is ideal to be used in any clinical situation, from single crowns to more complex multiple rehabilitations.

ø 3.80 ø 4.20

Range of CSR-DAT heights

diameter height

ø 3.80 mm 6.50, 8.50, 10.00, 11.50, 13.00, 15.00, 18.00

ø 4.20 mm 6.50, 8.50, 10.00, 11.50, 13.00, 15.00, 18.00

8 THE IMPLANTS

The more coronal portion presents a bevel which allows the realization of implant Platform Switching.

The more coronal segment, with a 50° triangular thread and a pitch of 0.30 mm, has a tapered morphology, to obtain a great primary stability.

The central portion is cylindrical, has a 50° triangular thread with 0.60 mm pitch.

The apex is tapered, with 50° triangular thread more accentuated than the central segment, to facilitate the insertion also in very compact bone.

The apex has a rounded shape and presents 4 incisions that increase the penetration ability and the antirotational aspect. They performe as decompression and release area for the blood clot.

9 THE IMPLANTS

ZirTi surfaces

CSR-DAT implant presents a ZirTi surface, characterized by sand-blasting with zirconium oxide and etching with mineral acids.

Sand-blasting with zirconium oxide and etching with mineral acids are processes that give the surface a characteristic micromorphology capable of increase significantly the bone-to-implant contact area and promoting osseointegration.

ZirTi surfaces seen at 4,000 and 10,000 magnifications using a scanning electron microscope

Image of a ZirTi surface portion captured with a radio-frequency optical interferometer: the micromorphology of the surface and the regularity of the peaks obtained with sand- blasting and etching treatments can clearly be noticed.

10 THE IMPLANTS

Table of colour codes

A colour code system has been defined in the CSR-DAT implant system to identify the endosseous diameter of the implant. Transfers for taking impressions, laboratory analogs, final drills and the sequence on the surgical tray are also identified with the colour code.

implant ø 3.80 4.20

colour code on the packaging and reference on the surgical tray

connection ø 3.00 ø 3.00 platform ø ø 4.10 ø 4.50 main dimensions

ø 3.80 ø 4.20

final drill

fixation screw colour code

M 1.8 M 1.8

transfer colour code

analogue colour code

11 THE RANGE

CSR-DAT implants

CSR-DAT implants are characterized by a hybrid morphology designed to obtain a great primary stability in any clinical situation, exploiting wherever possible the bicortical engagement. They are available in two diameters sharing the same conical connection of ø 3.00 mm.

12 THE RANGE

CSR-DAT implants are characterized by a hybrid morphology designed to obtain a great 3.80 mm 4.20 mm primary stability in any clinical situation, exploiting wherever possible the bicortical engagement. They are available in two diameters sharing the same conical connection of ø 3.00 mm. 6.50 VSR-ZT-380-065 VSR-ZT-420-065

ø 4.10 ø 4.50 ø 4.20 ø 3.80 6.50 6.50 ø 2.80 ø 3.30

8.50 VSR-ZT-380-085 VSR-ZT-420-085

ø 4.10 ø 4.50

ø 3.80 8.50 ø 4.20 8.50 ø 2.80 ø 3.30

10.00 VSR-ZT-380-100 VSR-ZT-420-100

ø 4.10 ø 4.50

ø 3.80 10.00 ø 4.20 10.00 ø 2.80 ø 3.30

11.50 VSR-ZT-380-115 VSR-ZT-420-115

ø 4.10 ø 4.50

ø 4.20 ø 3.80 11.50 11.50 ø 2.80 ø 3.30

13.00 VSR-ZT-380-130 VSR-ZT-420-130 ø 4.10 ø 4.50

ø 3.80 ø 4.20 13.00 13.00

ø 2.80 ø 3.30

15.00 VSR-ZT-380-150 VSR-ZT-420-150

ø 4.10 ø 4.50

ø 3.80 15.00 ø 4.20 15.00

ø 2.80 ø 3.30

18.00 VSR-ZT-380-180 VSR-ZT-420-180 ø 4.10 ø 4.50

ø 3.80 18.00 ø 4.20 18.00

ø 2.80 ø 3.30

surgical VSR-VT VSR-VT cover screw

Every implant is supplied with its own surgical cover screw. Surgical cover screws are also available individually in sterile packs, and must be tightened to 8–10 Ncm.

See technical characteristics of Gr. 4 titanium on page 53. 13 SURGICAL INSTRUMENTS

Surgical kit

The surgical kit of the CSR-DAT implant system is designed for maximum simplicity of use and immediacy for the correct sequence of the instruments required. Made of surgical stainless steel, the instruments descriptions are screen-printed on the tray to allow an easier identification and to correctly replace them after cleaning and sterilization procedure, marked with a system of colour codes that follow the most suitable surgical procedures for the two implant diameters. The kit contains stops that allow drills to be used safely. These stops are extremely practical, because they can be fitted and removed manually from drills in the tip≥shank direction. The kit also contains Easy Insert drivers for the correct insertion of the fixtures, and all the instruments necessary for the prosthetic phase of the insertion of CSR-DAT implants.

The kit contains a practical torque wrench to control the The kit consists of a Radel case with a surgical tray torque applied for the insertion of implants. designed to hold and display instruments in a guided order of use. The sequences of the instruments to be used are indicated by coloured marks.

The compact dimensions of the case make it particularly practical for daily use and transport.

14 SURGICAL INSTRUMENTS

description code

Complete surgical kit of the instruments ZCSR-INT necessary for CSR-DAT implants

Radel instrument tray for instruments CSR-TRAY*

* The code CSR-TRAY is followed by a letter and a number indicating the release version of the kit. The tray may be updated and varied if Sweden & Martina considers it opportune to develope or improve it.

Important warning The surgical kit also contains a non-sterile test implant that must not be used clinically, and can be easily recognized because it is entirely anodized in blue; it is recommended to use this implant for trials on models before starting to use implants clinically, so as to become familiar with the implant system and its respective instruments.

Table of colour codes

A colour code system has been defined in the CSR-DAT implant system to identify the endosseous diameter of the implant. Final drills and the sequence on the surgical tray are also identified with the colour code.

implant ø 3.80 4.20

colour code on pack

15 SURGICAL INSTRUMENTS

CSR-DAT kit

1 2 3 4 Precision Pilot Intermediate Stop drill drill drill CSR-STOP-2028-065 FS-230 CSR-FP-200 CSR-FI-280 CSR-STOP-2028-085 CSR-STOP-2028-100 CSR-STOP-2028-115 CSR-STOP-2028-130 CSR-STOP-2028-150

22 Parallelism pins PP-2/28

1 2 3 5

4 7 21 Screwdriver for abutments 22 AVV2-ABUT

20 P.A.D. transfer screw for manual screwing PAD-VTRAL-140-MAN

19 Drivers for fixation screws 21 20 19 17 HSM-20-CA

18

18 17 16 Surgical screwdrivers Prosthetic screwdrivers Extension HSMXS-20-DG HSM-20-DG HSML-20-DG HSM-20-EX HSML-20-EX HSMXL-20-EX B-AVV-CA3

16 SURGICAL INSTRUMENTS

5 6 7 8 9 Final Final Stop Countersink Extension for drill drill CSR-STOP-3236-065 drill surgical drills CSR-FF-320 CSR-FF-360 CSR-STOP-3236-085 CSR-FC PROF-CAL3 CSR-STOP-3236-100 CSR-STOP-3236-115 CSR-STOP-3236-130 CSR-STOP-3236-150

10 Extension BPM-15

6 8 9

11 Adaptor for torque wrench with control lever T W L-AV V-E X 10 11 12

12 Torque wrench with control lever TWL

13

15

16 14

15 14 13 Easy Insert driver Drivers Adaptor EASY4-EX230-EX EASYC4-EX230-CA EASYL4-EX230-CA BC-EX230 BL-EX230 AVV-CA-DG-EX

17 SURGICAL INSTRUMENTS

General indications

The surgical instruments designed for use with the implant systems manufactured by Sweden & Martina are reusable medical devices intended for temporary use in the oral cavity (no more than 60 minutes), re-usable. The functions of the surgical instruments are to prepare sites for Sweden & Martina implants, to insert the implants in the sites, to tighten and unscrew all the connecting screws (surgical cover screws, healing abutments, screws for posts, abutments, prosthesic screws, transfer screws, etc.).

The surgical instruments manufactured by Sweden & Martina are designed for use with dental implants manufactured by Sweden & Martina. Use of surgical instruments for operations with other implants than those manufactured by Sweden & Martina limits the responsibility of Sweden & Martina and renders the product warranty void. Sweden & Martina declines all responsibility for use of any non-original instruments. Sweden & Martina surgical instruments are sold in NON-STERILE packs. Before use, they must be cleaned, disinfected and sterilized according to the instructions reported below. Failure to follow these warnings may expose the patient to infections. The materials used for production of the surgical instruments manufactured by Sweden & Martina were selected based on the properties indicated for their intended use according to Directive 93/42/EEC, implemented in Italy with Law 46/97, Annex I – Essential Requirements, point 7.1.

Each packaging indicates the code, description of the contents and batch number. These same details, which are also indicated on the labels inside the packs, must always be provided by the practitioner in any relevant correspondence. All the devices are identified by an instrument code, which is laser marked onto the body of each instrument. If there is not enough space to include the full code, the elements for unequivocally identifying the device (e.g. diameter or length) are provided. When handling the devices, both during use and during cleaning and sterilization procedures, it is recommended to use surgical gloves for personal protection from bacterial contaminations. Failure to follow these instructions may cause cross-infection.

Key to the implant codes: surgical instruments

Implants are coded with “mnemonic” codes that allow easy identification of the piece. Below is a table showing how the mnemonic codes work using various types of instruments as examples.

examples component type and diameter length implant type

The range of instruments The “CSR” code indicates the Normally it is the ø of the This measurement is normally is vast, we indicate some CSR-DAT implant system. implant for the insertion or of linked to the height of the examples of the main families the preparation for which the component, or to other of instruments. instrument should be used. important measurements that characterise it, or it is a value that defines the shank of the instrument.

CSR-FF-320 CSR-FF: Final drill 3.20: for the preparation of a - fixture with ø 3.80

CSR-STOP-3236-065 CSR-STOP: Stop for the 3236: for use with 320 and 065: for an implant with final drill 360 drills H. 6.50 mm

PP-2/28 PP: Parallelism pin 2/28: from 2.00 mm to 2.80 mm -

18 SURGICAL INSTRUMENTS

Drills

All Sweden & Martina drills are made of surgical steel with high resistance to corrosion and wear. They are intended for mechanical use, i.e. they have a shank with a right angle attachment and must be used with a suitable micromotor. The extreme accuracy of design and production allows use completely free from vibrations and oscillations. However, incorrect insertion of the instruments in the handpiece will cause instrument vibration, eccentric rotation, early wear and shaft buckling. Suitable surgical micromotors only should be used. Micromotors should be checked regularly by their manufacturers, according to the indications given by the manufacturers, to prevent potential malfunctions (e.g. axle shifts for transmission shafts, worn or faulty , etc.).

Failure to follow the instructions provided may cause surgical complications and consequent damage to the patient‘s health. It is recommended to use the rotation speeds indicated in the procedures on page 46 to prevent the development of bone necrosis. Lever movements increase the risk of instrument breakage and should therefore be avoided. Changes in speed should be avoided in general. Never apply pressure such as to force the instrument to stop rotating. This could lead to an excessive increase in heat in the tissues being drilled, with consequent bone necrosis, and damage both the instrument and the appliance used (micromotor). This could also lead to breakage of the instrument. Using an intermittent approach, with a back and forth movement in a vertical direction, prevents overheating and wear of the working part and an undesirable increase in the temperature in the tissues being cut. Suitable coolant liquids must be used. Inadequate irrigation can lead to bone necrosis. Drill wear depends on a large extent on the type and density of the drilled bone: harder bone leads to greater instrument wear.

For greater safety and caution, given the device’s capacity for resistance to wear, drills should not be used for more than 20 work cycles and should be replaced earlier if the instruments lose their cutting ability. These recommended 20 cycles should be considered a rough guide. Always check the instrument’s residual cutting capacity after each procedure. Sweden & Martina declines all responsibility in cases of excessively intense use. Never sharpen drills before use. Never use damaged, buckled or worn instruments.

19 SURGICAL INSTRUMENTS

Precision drill FS-230

The precision drill is made of surgical stainless steel. It is used to cut the cortical bone, so it is very sharp and pointed. The design of the blades ensures efficient cutting with both the tip and the edge. It has a maximum diameter of 2.30 mm. The laser marking at 4.80 mm indicates the maximum depth of insertion of the drill to obtain an adequate guide hole for subsequent drills.

4.80 mm

Important warning The precision drill is supplied complete with a protective silicone sheath to protect it during transport, and it must be removed before the first use. Since this drill is extremely sharp, special caution is required during handling.

Pilot drill CSR-FP-200

The pilot drill is cylindrical and has a diameter of 2.00 mm. It is designed for the preparation of the hole that will receive the implant. The drill is easy to identify, thanks to the presence of a white ring and a laser-etched code on the drill shank. It has laser-etched depth marks and a spiral shape with two cutting edges. It must be used with abundant external irrigation.

LL LL: Total length of the working part, including the tip. LS LS: Length of the tip. This measurement must be calculated in addition to the length of the preparation hole. 0 6.5 8.5 10.0 11.5 13.0 15.0

Important warning The drills always make a hole that is longer than the implant to be inserted. The oversizing (LS) is equal to the difference between the lenght of the working part of the drill and the nominal height of the implant.

Please note: laser marks are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site. In any case it is recommended to respect the overpreparation warning above mentioned.

code ø LS LL

CSR-FP-200 2.00 0.58 18.58 20 SURGICAL INSTRUMENTS

Intermediate drill CSR-FI-280

The intermediate drill has three cutting edges, suitable for progressively widening the preparations in relation to the diameter of the drills to be used in succession. It has two small steps with an initial guide with a progressive diameter of 2.00 mm and a final diameter of 2.80 mm. It presents laser-etched reference markings that range from a height of 6.50 mm to 15.00 mm.

LL LL: Total length of the working part, including the tip. LS LS: Length of the tip. This measurement must be calculated in addition to the length of the preparation hole. 0 6.5 8.5 10.0 11.5 13.0 15.0

Important warning The drills always make a hole that is longer than the implant to be inserted. The oversizing (LS) is equal to the difference between the lenght of the working part of the drill and the nominal height of the implant.

Please note: laser marks are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site. In any case it is recommended to respect the overpreparation warning above mentioned.

description code

intermediate drill CSR-FI-280

18.00 ø2.80

ø2.50 ø2.00 0.58

21 SURGICAL INSTRUMENTS

Pilot drill and intermediate drill stops

Stops are devices to be fitted in the tip≥shank direction on drills suited to receive them. They make it possible to restrict the working length of a drill to a pre-set height. The same set of stops is used on both the pilot drill and the intermediate drill, because they have the same attachment: the stops therefore have both a white ring and a black ring, indicating the two drills with which they can be used.

pilot drill and intermediate drill related stops

CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- 2028-065 2028-085 2028-100 2028-115 2028-130 2028-150 Stop 6.50 mm Stop 8.50 mm Stop 10.00 mm Stop 11.50 mm Stop 13.00 mm 15.00 mm stop for pilot drill and for pilot drill and for pilot drill and for pilot drill and for pilot drill and for pilot drill and intermediate drill intermediate drill intermediate drill intermediate drill intermediate drill intermediate drill

For implants H. 18.00 mm the preparation must be executed without the stops assistance for the entire lenght of the working part of the drill (in this case at the end of this part the widening works as a security stop).

Always check the stop to be inserted at the desidered height. Incomplete insertion may reduce the preparation height. Any insertion difficulties can be solved by loosening the stop tabs slightly, using forceps. It is also recommended to check the retention precticed by the stop, as if retention is too weak the instrument will fall off the drill during operation.

If the retention capacity of the stops is reduced, simply tighten the tabs by hand or using forceps.

22 SURGICAL INSTRUMENTS

Final drills

Made of surgical steel with high resistance to corrosion and wear, CSR-DAT final drills have a number of cutting edges proportioned to the diameter of the hole, in order to allow a continue and homogeneous cutting movement and a better stability of the instrument during the surgical phases.

The final drills are available in two diameters of 3.80 mm and 4.20 mm. These two drills present two steps with progressively increased diameter to allow the guide of the tip in the previous preparation (see the table below for the reference measurements). When fitted with the depth stops, that are common to both drills, they can be used to prepare all heights for each diameter.

LL

LL: Total length of the working part, LS including the tip. LS: Length of the tip. This measurement must be calculated in addition to the 0 6.5 8.5 10.0 11.5 13.0 15.0 length of the preparation hole.

Important warning The drills always make a hole that is longer than the implant to be inserted. The oversizing (LS) is equal to the difference between the lenght of the working part of the drill and the nominal height of the implant.

Please note: laser marks are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site. In any case it is recommended to respect the warning overpreparation above mentioned.

implant ø 3.80 4.20

final drill CSR-FF-320 CSR-FF-360

ø 3.20 18.00 ø 3.60 18.00

ø 2.60 ø 3.00 ø 2.00 ø 2.60 0.58 0.75

These drills must be used together with the depth stops that are also included in the surgical kit.

23 SURGICAL INSTRUMENTS

Final drills stops

The surgical kit contains a set of stops to limit the working length of the drills to predetermined heights. The stops are designed to be fitted from the tip of both the final drills: for this reason they have two coloured reference rings indicating the two drills with which they must be used.

final drills related stops

CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- CSR-STOP- 3236-065 3236-085 3236-100 3236-115 3236-130 3236-150 Stop 6.50 mm Stop 8.50 mm Stop 10.00 mm Stop 11.50 mm Stop 13.00 mm Stop 15.00 mm for final drill for final drill for final drill for final drill for final drill for final drill

For implants H. 18.00 mm the preparation must be executed without the stops assistance for the entire lenght of the working part of the drill (in this case at the end of this part the widening works as a security stop).

As indicated earlier for the stops for pilot and intermediate drills, in this case as well it is advisable to always check that the stop is fitted at the desired height. Incomplete insertion may reduce the preparation height. Any insertion difficulties can be solved by loosening the stop tabs slightly, using forceps. It is also recommended to check the retention exerted by the stop, as if retention is too weak the instrument will fall off the drill during operation.

If the retention capacity of the stops is reduced, simply tighten the tabs by hand or using forceps.

24 SURGICAL INSTRUMENTS

Countersink drill

This drill is designed to prepare the site of the coronal part of CSR-DAT implants, and therefore the tip is not sharp, but acts as a guide. The laser marking indicates the two different insertion depths related to the two implant diameters: the edge of the marking closest to the apex indicates the preparation for implants with ø 3.80 mm, broadening out the neck to 4.05 mm, the more coronal edge indicates the preparation for implants with ø 4.20 mm, broadening out the neck to 4.45 mm.

Important warning Laser marks are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site, always considering the overpreparation lenght of the tip.

description code

countersink drill CSR-FC

ø 4.45 ø 4.05 5.60

25 SURGICAL INSTRUMENTS

Drills for distal sectors

As an option, shorter drills are available with a 14 mm long shank and total length of 30 mm, to be used without stop. These drills are very practical in distal sectors with a limited space of the oral cavity.

0 7. 0 8.5 10.011.5 13.0 15.0

drills for distal sectors

FPT5-200-LXS FFT5-280-LXS FFT5-290-LXS FFT5-300-LXS Cylindrical drill ø 2.00 mm Cylindrical drill ø 2.80 mm Cylindrical drill ø 2.90 mm Cylindrical drill ø 3.00 mm

15.50 15.50 15.50 15.50

0.58 0.81 0.84 0.87

FFT5-320-LXS FFT5-330-LXS FFT5-340-LXS FFT5-360-LXS Cylindrical drill ø 3.20 mm Cylindrical drill ø 3.30 mm Cylindrical drill ø 3.40 mm Cylindrical drill ø 3.60 mm

15.50 15.50 15.50 15.50

0.92 0.95 0.98 1.06

Please note: the drills always make a hole that is longer than the implant to be inserted. The oversizing is equal to the height of the tip of the drill being used. The measurements are given in the chart above.

Important warning Unlike the drills dedicated only to the CSR-DAT system on which the first marking corresponds to a preparation depth of 6.50 mm, the first marking on drills for distal sectors is at 7.00 mm. In addition, the maximum preparation length is 15.00 mm, so they cannot be used for preparations with a length of 18.00 mm. Particular attention must be given to these differences when planning to use drills for distal sectors to avoid damaging of delicate anatomical structures by overpreparing the length of the surgical site.

Important warning Laser marks are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site, always considering the overpreparation lenght of the tip. 26 SURGICAL INSTRUMENTS

Osteotomes

A complete set of osteotomes has been designed for the expansion of thin crests, for mini-crest lifts and for compacting poorly mineralised bone, to be used as an alternative to the final drills. The osteotomes are manual invasive surgical instruments, intended for creating holes in bone, especially in presence of poor quality bone, and to compact preparation sites by progressively widening them, condensing the bone onto the walls of the hole. They can have a flat or concave tip, depending on whether the bone has to be pushed or cut, and are tapered to different degrees depending on the shape to be given to the site destined to receive implants of a pre-ordered shape. The sequence of use must be determined according to the level of bone density and the preparation that is to be obtained.

To permit more practical use, osteotomes for CSR-DAT implants have laser marks at different heights on the tip to indicate the various implant heights.

11.50 10.00 13.00 8.50 15.00 7.00 18.00

osteotomes

E-OS-020-PP E-OS-090-PP E-OS-160-PC E-OS-200-PC E-OS-240-PC ø 0.20 Osteotome ø 0.90 Osteotome ø 1.60 Osteotome ø 2.00 Osteotome ø 2.40 flat tip flat tip concave tip concave tip concave tip

ø 0.20 ø 0.90 ø 1.60 ø 2.00 ø 2.40

OS-TRAY* Universal Radel plastic instrument tray for osteotomes. Supplied empty, with space for up to 12 instruments.

Important warning Unlike the drills dedicated only to the CSR-DAT system, on which the first marking corresponds to a preparation depth of 6.50 mm, the first marking on drills for distal sectors is at 7.00 mm. Particular attention must be given to these differences when planning to use drills for distal sectors to avoid damaging of delicate anatomical structures by overpreparing the length of the surgical site.

*The code OS-TRAY is followed by a letter and a number indicating the release version of the tray. 27 SURGICAL INSTRUMENTS

Easy Insert drivers

The CSR-DAT implant does not require a mounter for the insertion into the implant site, it is engaged directly inside the connection by practical Easy Insert drivers, designed to guarantee a safe grip, to prevent deformations to the corners of the connections and at the same time to allow easy removal from the implant. The use of these drivers makes the surgical procedure of insertion extremely simple.

A single instrument for the insertion of both CSR-DAT implant diameters.

Easy Insert drivers aid visibility of the operating field, do not occupy much space, and allow the adjusting of the connection hexagon to the most suitable prosthetic direction, because they have a hexagonal visual indicator corresponding to the hexagon of the prosthesis, with black laser-etched dots on alternating faces.

Cross-section view of the conventional drivers engagement

Cross-section of the Easy Insert drivers engagement

The special patented design of Easy Insert drivers prevents deformations of the implant connection and ensures that the faces (and not the corners) of the instrument make contact with the faces of the implant hexagon. The dodecagonal design of the drivers prevents deformations to the implant connection, thus guaranteeing extremely high prosthetic stability and precision.

28 SURGICAL INSTRUMENTS

When using the Easy Insert driver with the torque wrench with control lever or ratchet, as when using any other instrument for inserting implants with a dynanometric key, it is likewise advisable to take care to keep the working axis as perpendicular as possible. It is also fundamental for the movement performed with the ratchet during tightening to be slow and uniform, avoiding brusque movements as much as possible. If the precautions of use are not followed and the maximum torque is exceeded, the instrument should be broken: for this reason is provided with a default breaking point located over the dots, to allow the operator to remove the driver from the implant without any difficulties. It is recommended to grip the ratchet in the part closest to the connection and to maintain a light and constant pressure with one finger, to allow greater stability during tightening.

description code kit

Short driver with shank for right angle EASYC4-EX230-CA ZCSR-INT

Long driver with shank for right angle EASYL4-EX230-CA ZCSR-INT

Driver with connector for EASY4-EX230-EX ZCSR-INT dynamometric key

Maintenance and care of Easy Insert drivers

The Easy Insert drivers are supplied prefitted with specific titanium O-rings. Since they are mechanical components, the retainer rings are subject to wear over time and can lose their functionality. The O-rings cannot be replaced, but it is necessary to replace the instrument. The Easy Inserts were tested to be good for 40 uses in the worst conditions of use. This limit may however be subject to variations, depending on conditions of use. It is however always recommended to check the correct functionality of Easy Insert drivers every time they are cleaned and sterilized. For this reason, and to allow the practitioner to become familiar with the use of Easy Insert drivers, the surgical kit contains an untreated non-sterile “test implant”, which can be easily recognized because it is entirely anodized in blue. Cross-section view of the conventional drivers engagement Important warning Cross-section of the Easy Insert It is recommended to use the Easy Insert drivers with a torque between 50 Ncm and 70 Ncm. drivers engagement Thanks to tests performed on models, it has been observed that from 70 Ncm to 100 Ncm slight frictions between the instrument and the implant connection are possible, which can be avoided with a slight shaking movement of the Easy Insert in the connection. From 100 Ncm to 200 Ncm higher frictions are possible, which can be solved with a simple counter-rotation movement (at 40 Ncm) in order to remove the instrument from the connection. Moreover it is recommended to end the bone tapping phase using the dynamometric key with control lever TWL.

29 SURGICAL INSTRUMENTS

Drivers

These instruments are made of stainless steel and can be used to remove implants that have already been positioned. Drivers must be used ONLY for the removal of the implants and not for the screwing. Therefore CSR-DAT implants must be screwed in only with Easy Insert drivers.

description code kit

Short driver BC-EX230 ZCSR-INT

Long driver BL-EX230 ZCSR-INT

Important warning These drivers, having a full hexagon, may cause deformations of the hexagon of the implant if they are used in the screwing from 40 Ncm, risking to influence all the following prosthetic rehabilitation phase. Moreover, since they have the full hexagon, they get blocked much more easily with the implant hexagons, and often become very difficult to remove.

Drivers for surgical cover screws and fixation screws

The surgical kit contains several instruments that can be used to screw and unscrew surgical cover screws, transfer screws for posts and abutments and more in general for all the screws of the CSR-DAT system: the slightly conical coupling between the driver and the screw allows an appropriate retention when carrying the screw in the oral cavity. Drivers are all made of surgical steel.

Important warning Excessive torques can damage the internal thread of the implant or of the sharp edges of the connecting screws and damage the thread of the DAT drivers, causing also severe intra-surgical and prosthetic complications. The recommended torque for the tightening of the different components are summarized in the following chart:

description recommended torque

Surgical cover screws, healing abutments (manually) 8-10 Ncm

All prosthetic screws 20-25 Ncm

All prosthetic components screwed directly onto an implant 25-30 Ncm

Transfer fixation screws (manually) 8-10 Ncm

30 SURGICAL INSTRUMENTS

Digital surgical screwdrivers

The design of digital surgical screwdrivers makes them extremely practical for tightening surgical cover screws during surgery and when uncovering and handling healing abutments. They must not be used when working with definitive prostheses, as they do not allow tightening torque to be controlled.

description code kit

Screwdriver for surgical cover screws and fixation HSMXS-20-DG ZCSR-INT screws, digital, extra-short

6.30

15.00

Screwdriver for surgical cover screws and fixation HSM-20-DG ZCSR-INT screws, digital, short

12.30

21.00

Screwdriver for surgical cover screws and fixation HSML-20-DG ZCSR-INT screws, digital, long

14.80

26.90

Important warning It is recommended to pass a thread through the hole on the top of the digital screwdriver to prevent it falling.

31 SURGICAL INSTRUMENTS

Prosthesic screwdrivers

The screwdrivers with upper hexagonal connection have been designed to be used with the The surgical kit of the CSR-DAT implant system includes a special dynamometric key with a dynamometric ratchet with function of torque control. The kit contains short and long control lever (TWL). The torque wrench can be used to indicate the value of the torque applied versions; an extra-long version is also available on request, necessary when the length of the hole during the surgical phases of screwing and unscrewing, showing values from 10 to 90 Ncm. for the screw to pass inside the posts is greater than 13.00 mm. It is supplied complete with a specific adaptor that allows it to be used with surgical instruments with a hexagonal connection. The torque wrench with control lever TWL is a multipurpose instrument that can be dismantled, description code kit and it is sold as non-sterile.

Screwdriver for fixation screws, with hexagonal HSM-20-EX ZCSR-INT connector for ratchet or hand knob, short Adaptor for torque wrench

7.90 13.90

Screwdriver for fixation screws, with hexagonal HSML-20-EX ZCSR-INT connector for ratchet or hand knob, long

15.00 Ratchet head Handle 21.00

Screwdriver for fixation screws, with hexagonal HSMXL-20-EX ZCSR-INT connector for ratchet or hand knob, extra-long

25.00 31.00

Driver for fixation screws, with right angle shank HSM-20-CA ZCSR-INT

12.60 27.00

Important warning All the ratchet drivers have a red polymer O-ring in the connecting hexagon that guarantees friction between the instruments and therefore a correct grip of the components. This O-ring must be checked periodically and replaced when worn or when no longer able to exert the correct friction. A kit of 5 spare O-rings is available, which can be ordered with code ORING180-088.

Spare O-rings

description code kit

Kit of 5 spare O-rings for all accessories ORING180-088 Not included with hexagonal connection for in the surgical dynamometric key and ratchet kit, available separately

32 SURGICAL INSTRUMENTS

Torque wrench with control lever TWL

The surgical kit of the CSR-DAT implant system includes a special dynamometric key with a control lever (TWL). The torque wrench can be used to indicate the value of the torque applied during the surgical phases of screwing and unscrewing, showing values from 10 to 90 Ncm. It is supplied complete with a specific adaptor that allows it to be used with surgical instruments with a hexagonal connection. The torque wrench with control lever TWL is a multipurpose instrument that can be dismantled, and it is sold as non-sterile.

Adaptor for torque wrench

Ratchet head Handle

Every time this instrument is used, it must first be cleaned and sterilized following the instructions on page 40. Adequate maintenance, carried out by scrupulously following all the steps indicated for dismantling and reassemblying of the torque wrench during cleaning operations is essential for its correct use and to prolong its shelf life. The personnel using this instrument must be suitably trained and must have read the instructions given in this manual before proceeding with any operations with it.

After sterilization and before use, check that the first mark on the scale is aligned with the arrow. The instrument must be tested for correct assembly and correct funcionality every time it is used.

Important warning The arm of the torque wrench must not move beyond the end of the scale, as this could lead to inaccurate torque readings.

The torque wrench can also be used as a fixed key, without using the scale, by using the entire handle as a lever. In this case, it must not exceed the torque value of 150 Ncm. The personnel responsible for the use and maintenance of this instrument must check it for possible signs of deterioration of the tightening, insertion and torque mechanisms. The single components of the torque wrench are not interchangeable, and it is not possible to use a component from one key to replace a component on another. If any component of the torque wrench is lost, always return the entire instrument to Sweden & Martina S.p.A. for all necessary repairs. Components for the assembly of the torque wrench with control lever are not sold individually. Failure to respect the instructions given may cause aesthetic problems and be damaging for the patient‘s health.

33 SURGICAL INSTRUMENTS

Torque control ratchet CRI5-KIT

For additional use, a special ratchet (CRI5-KIT) is available, with its own adjustment key, for quickly screwing the torque adjustment ring nut, and with gel lubricant for maintenance. The dynamometric key can be used with torque adjustment from 10 to 70 Ncm or in a locked position without torque control. When using as a prosthetic ratchet for fastening the screws, refer to the torque values indicated for the fastening of the prostheses. The CRI5-KIT dynamometric key is a multipurpose instrument that can be dismantled, and it is sold as non-sterile.

Ratchet head cover

Pawl wheel

Wheel stop tooth

Cover fastening screw Torque adjustment ring nut

Ratchet head Handle Guide pin Spring Hexagonal tip of the torque adjustment screw

Before each use, this instrument must be cleaned and sterilized according to the instructions on page 42. Adequate maintenance, carried out by scrupulously following all the steps indicated for dismantling and reassemblying of the torque wrench during cleaning operations is essential for its correct use and to prolong its shelf life. The personnel using this instrument must be suitably trained and must have read the instructions given in this manual before proceeding with any operations with it. After sterilization, the ratchet is ready for use. The instrument must be tested for correct assembly and correct funcionality every time it is used, whether for surgical and prosthetic procedures. The torque is adjusted by aligning the marking of the desired torque in the circular opening of the handle. The “IN” arrow legible on the top of the head indicates the screwing position of the key. The “OUT” arrow legible on the top of the head indicates the loosening or unscrewing position. An unlimited torque position is obtained by positioning the torque adjustment device up to the line marked “R” on the handle of the ratchet body.

34 SURGICAL INSTRUMENTS

The ring nut may be screwed and unscrewed by hand, but to speed up these operations the kit also contains a driver that allows it to be turned quickly. Any deterioration of the screwing, insertion and torque mechanisms must be checked by personnel responsible for the use and maintenance of this . The pieces of this mechanism are not interchangeable; one piece from one key cannot be replaced by a piece from another key as each ratchet is calibrated INDIVIDUALLY. If a piece is lost, please return the instrument to Sweden & Martina for repair. No components for assembling the ratchet can be sold individually. Failure to follow the instructions provided may cause problems of maintenance and stability of the prosthesis.

Important warning Torque is always adjusted by screwing in/unscrewing the sleeve at the end of the instrument handle. Torque must always be adjusted upwards, starting from a value lower than that required and tightening the adjustment sleeve in a clockwise direction until the desired value is reached. This means that if a torque value lower than that used previously is to be set, the adjustment sleeve must be slackened by two whole turns beneath the new torque value required, and then tightened again in a clockwise direction to the desired value.

In order to set a torque To turn down a torque value of work value, turn the ring nut in the of the ratchet, first it is necessary clockwise direction until the to unscrew the ring nut in the wanted value. anticlockwise direction until reaching a value inferior of the wanted one, then proceed with the clockwise direction screwing until the chosen torque.

35 SURGICAL INSTRUMENTS

Adaptors and extensions

description code kit

Extension for drivers, screwdrivers BPM-15 ZCSR-INT and manual drivers, with hexagonal connector for ratchet

Extension for surgical drills PROF-CAL3 ZCSR-INT

Screwdriver for right angle instruments B-AVV-CA3 ZCSR-INT with hexagonal connector for ratchet, digital

Driver for right angle and manual AVV-CA-DG-EX ZCSR-INT instruments and instruments with hexagonal connection for ratchet

P.A.D. transfer screw for manual PAD-VTRAL-140-MAN ZCSR-INT screwing

Carrier to transfer angled P.A.D. abutments PAD-CAR Not included into the oral cavity, sterilizable and in the surgical reusable. It must be fixed to abutments with kit, available screw PAD-VTRAL-140 separately

Important warning The extension PROF-CAL3 must be used only together with the surgical drills. In case it is used with other instruments, it is essential to not exceed the torque value of 50 Ncm, to prevent deformations of the extension that could compromise its successive use.

36 *The ZCSR code is followed by a letter and a number indicating the release version of the kit. SURGICAL INSTRUMENTS

Parallelism pins PP-2/28

The surgical kit contains six parallelism pins that can be used to check the insertion axis of the implants and the parallelism between more fixtures. They have one side with 2.00 mm diameter and the other with a diameter of 2.80 mm, in order to be used after drilling with same diameter drills.

ø 2.80 ø 2.00

description code kit

Parallelism pin with one side of ø 2.00 mm and PP-2/28 ZCSR-INT the other of ø 2.80 mm

Parallelism pins with laser-etched notches

As an option, parallelism pins with depth notches are also available, allowing the control of the preparation height during the first surgical step, thanks to the notches provided on the side with a diameter of ø 2.00 mm. As the notches have a slightly smaller diameter than the body of the pin, they can be clearly noted on intraoperative X-rays. The other side of the pin has a diameter of ø 2.80 mm and it has a hole in which a safety thread can be inserted. The small version of the pin, with the side with diameter ø 2.80 mm shorter than on the large version, may be useful with patients with a limited space in the oral cavity or for distal sectors.

27.15 mm 20.55 mm

ø 2.80 mm ø 2.00 mm ø 2.80 mm ø 2.00 mm 15.00 5.00 15.00 5.00 13.00 6.00 13.00 6.00 11.50 7. 0 0 11.50 7. 0 0 10.00 8.50 10.00 8.50

description code kit

Parallelism pin with depth lines, large PPTL-2-28 Not included in the surgical kit, available separately

Parallelism pin with depth lines, small PPTS-2-28 Not included in the surgical kit, available separately

Important warning It is recommended to pass a thread through the hole in the center of the pin to prevent it falling.

37 SURGICAL INSTRUMENTS

PROF3 depth gauge

It is a practical instrument which allows to verify the depth of the preparation holes and the distance between the implants. It is not included in any surgical kit, it can be ordered separately.

18.00 mm 15.00 mm 13.00 mm 11.50 mm 10.00 mm 8.50 mm 7.00 mm

X-ray templates

The surgical kits are supplied with x-ray templates for the graphic representation of all the CSR-DAT implant system measurements to allow choosing the most suitable implant diameters and lengths by means of radiographic or tomographic methods. The templates are available in three versions: in real dimensions, increased of 20% and 30%.

description code kit

X-ray template for CSR-DAT implants CSR-L100 02/16 rev CSR-L100 ZCSR-INT Real dimensions H 6.5 mm VSR-ZT-420-065 VSR-M-420-065 H 8.5 mm VSR-ZT-420-085 VSR-M-420-085 H 10 mm VSR-ZT-420-100 VSR-M-420-100 mm H 11.5 VSR-ZT-420-115 VSR-M-420-115 H 13 mm VSR-ZT-420-130 VSR-M-420-130 H 15 mm VSR-ZT-420-150 VSR-M-420-150 H 18 mm VSR-ZT-420-180 VSR-M-420-180 Fixture ø 4.20 mm Fixture H 6.5 mm VSR-ZT-380-065 VSR-M-380-065 H 8.5 mm VSR-ZT-380-085 VSR-M-380-085 H 10 mm VSR-ZT-380-100 VSR-M-380-100 mm H 11.5 VSR-ZT-380-115 VSR-M-380-115 H 13 mm VSR-ZT-380-130 VSR-M-380-130 H 15 mm VSR-ZT-380-150 VSR-M-380-150 H 18 mm VSR-ZT-380-180 VSR-M-380-180 Fixture ø 3.80 mm Fixture ø implant ø max

ø apex Impianto cilindrico Impianto conical DAT connection conical DAT Cylindrical implant with H con connessione conica DAT RIPRODUZIONE SCALA REALE - REAL DIMENSIONS REALE - REAL RIPRODUZIONE SCALA CSR-DAT

X-ray template for CSR-DAT implants CSR-L120 02/16 rev CSR-L120 ZCSR-INT 20% increased dimensions H 6.5 mm VSR-ZT-420-065 VSR-M-420-065 H 8.5 mm VSR-ZT-420-085 VSR-M-420-085 H 10 mm VSR-ZT-420-100 VSR-M-420-100 mm H 11.5 VSR-ZT-420-115 VSR-M-420-115 H 13 mm VSR-ZT-420-130 VSR-M-420-130 H 15 mm VSR-ZT-420-150 VSR-M-420-150 H 18 mm VSR-ZT-420-180 VSR-M-420-180 Fixture ø 4.20 mm Fixture H 6.5 mm VSR-ZT-380-065 VSR-M-380-065 H 8.5 mm VSR-ZT-380-085 VSR-M-380-085 H 10 mm VSR-ZT-380-100 VSR-M-380-100 mm H 11.5 VSR-ZT-380-115 VSR-M-380-115 H 13 mm VSR-ZT-380-130 VSR-M-380-130 H 15 mm VSR-ZT-380-150 VSR-M-380-150 H 18 mm VSR-ZT-380-180 VSR-M-380-180 Fixture ø 3.80 mm Fixture ø implant ø max

ø apex Impianto cilindrico Impianto conical DAT connection conical DAT Cylindrical implant with H con connessione conica DAT RIPRODUZIONE SCALA MAGGIORATA DEL 20% - DIMENSIONS ENLARGED BY 20% 20% - DIMENSIONS ENLARGED BY DEL MAGGIORATA RIPRODUZIONE SCALA CSR-DAT

X-ray template for CSR-DAT implants CSR-L130 02/16 rev CSR-L130 ZCSR-INT 30% increased dimensions H 6.5 mm VSR-ZT-420-065 VSR-M-420-065 H 8.5 mm VSR-ZT-420-085 VSR-M-420-085 H 10 mm VSR-ZT-420-100 VSR-M-420-100 mm H 11.5 VSR-ZT-420-115 VSR-M-420-115 H 13 mm VSR-ZT-420-130 VSR-M-420-130 H 15 mm VSR-ZT-420-150 VSR-M-420-150 H 18 mm VSR-ZT-420-180 VSR-M-420-180 Fixture ø 4.20 mm Fixture H 6.5 mm VSR-ZT-380-065 VSR-M-380-065 H 8.5 mm VSR-ZT-380-085 VSR-M-380-085 H 10 mm VSR-ZT-380-100 VSR-M-380-100 mm H 11.5 VSR-ZT-380-115 VSR-M-380-115 H 13 mm VSR-ZT-380-130 VSR-M-380-130 H 15 mm VSR-ZT-380-150 VSR-M-380-150 H 18 mm VSR-ZT-380-180 VSR-M-380-180 Fixture ø 3.80 mm Fixture ø implant ø max

ø apex Impianto cilindrico Impianto conical DAT connection conical DAT Cylindrical implant with H con connessione conica DAT RIPRODUZIONE SCALA MAGGIORATA DEL 30% - DIMENSIONS ENLARGED BY 30% 30% - DIMENSIONS ENLARGED BY DEL MAGGIORATA RIPRODUZIONE SCALA CSR-DAT

38 SURGICAL INSTRUMENTS

Cleaning, disinfection, sterilization and storage of the kit and of the surgical instruments

Attention! All the surgical instruments for dental implants are sold in NON-STERILE packs. Before use, they must be cleaned, disinfected and sterilised according to the following procedure validated by Sweden & Martina. These processes must be performed before use and before each subsequent reuse. Repetition of the processes described in this paragraph has minimal effect on the wear of these devices. Instruments should always be checked before use to ensure they are in good working order. Any instruments showing signs of wear must be immediately replaced with new devices. It is particularly important to check that the drivers grip properly inside the engagement wells on the heads of the screws to be lifted and tightened with the same. Failure to follow these instructions may cause cross-infections and intraoperative complications.

a. Cleaning Containers and transport to be used for washing: there are no special requirements. In case of automatic cleaning, use an ultrasound bath with a suitable detergent solution. Use neutral detergents only. Follow the manufacturer’s instructions concerning concentrations and washing times. Use demineralised water to prevent the formation of stains and marks. When draining, check the recesses of the devices, holes, etc. to make sure all residues have been completely removed. If necessary, repeat the cycle or clean manually. When cleaning manually: use a suitable, neutral detergent and follow the manufacturer’s user instructions. Brush the products with a soft-bristled brush under plenty of running water. Use the brush to apply the detergent to all surfaces. Rinse with distilled water for at least four minutes. Make sure plenty of running water passes through any holes. For drills with internal irrigation, use the special pins provided with the handpieces to ensure that the irrigation holes are completely clean and free of bone fragments or biological tissues. After rinsing, dry the devices thoroughly and place them inside suitable sterilisation bags. Do not exceed 120°C when performing a drying cycle in a washing and disinfection appliance.

b. Sterilization In a vacuum autoclave, proceeding as follows: – Autoclave (Gravity - Displacement Cycles) Temperature of 121°C with a minimum autoclave cycle of 30 minutes and a drying cycle of 15 minutes. – Autoclave (Dynamic - Air - Removal Cycles) Temperature of 132 ÷ 134°C with a minimum autoclave cycle of 5 minutes and a drying cycle of 20 minutes.

c. Storage After sterilisation, the product must remain in the sterilisation bags. The bags should only be opened immediately prior to reuse. In normal conditions, sterilisation bags maintain the sterility of the contents, unless the wrapping is damaged. Therefore, do not use components if the bags in which they were kept are damaged, and resterilise in new bags before using them again. The storage time of products sterilised inside the bags should not exceed that recommended by the manufacturer of the bags. The product must be stored in a cool dry place, away from sunlight, water and sources of heat.

39 SURGICAL INSTRUMENTS

Cleaning, disinfection, sterilization and storage of the torque wrench with control lever TWL

The processes described below must be performed before use and before each subsequent operation. Repetition of the processes described in this paragraph has minimal effect on the wear of the device. The failure to follow these instructions may cause cross-infections.

a. Cleaning Containers and transport to be used for washing: there are no special requirements. As soon as possible after each use, the key must be placed in a container filled with a disinfecting/cleansing solution and covered with a cloth. This prevents the desiccation of the contaminating agents coming from the patient, and dissolves them, thus making cleaning easier and more effective.

Completely disassemble the key as shown below:

Press the driver and remove it from the head of the torque wrench, then remove the head by pressing inside the hollow, and delicately pull it out. The three separate components are now ready for cleaning.

In case of manual cleaning, clean the outer and inner surfaces of the instrument mechanically under hot water with a soft bristled brush. Use a suitable neutral detergent and follow the manufacturer’s user instructions. Use the brush to apply the detergent to all surfaces. Rinse with distilled water for at least four minutes. Make sure the running water passes abundantly through the passages. In case of automated ultrasound cleaning: use an ultrasound bath with a suitable detergent solution. Use neutral detergents only. Follow the manufacturer’s instructions concerning concentrations and washing times. Use demineralised water to prevent the formation of stains and marks. During this cycle, avoid contact between the pieces because this causes the machined surfaces to deteriorate, and consequently, loss of precision of the torque measurement.

When draining, check the recesses of the devices, holes, etc. to make sure all residues have been completely removed. If necessary, repeat the cycle or clean manually. Observation: blood residues or other deposits reduce the efficacy of the sterilisation process, which is why it is important to clean thoroughly. During cleaning, avoid sprays or jets of liquid and adopt adequate protections. Avoid contact between this instrument and other nickel-plated instruments.

Components must be reassembled before sterilization.

40 SURGICAL INSTRUMENTS

This procedure is important in order to preserve the precision of the instrument within the following tolerances:

10 Ncm ± 0,75 Ncm

30 Ncm ± 1,5 Ncm

50 Ncm ± 2,5 Ncm

70 Ncm ± 3,5 Ncm

90 Ncm ± 4,5 Ncm

After cleaning, connect the torque wrench head to the Press the driver into the torque wrench until a click is body, pushing the components together and rotating heard. The arrow on the torque wrench head indicates them in opposite directions until a click is heard. the direction of operation.

Place the device in a suitable sterilization bag. Disassembly and reassembly operations must be carried out following the indications provided here. b. Sterilization In a vacuum autoclave, proceeding as follows: – Autoclave (Gravity - Displacement Cycles) Temperature of 121°C with a minimum autoclave cycle of 30 minutes and a drying cycle of 15 minutes. – Autoclave (Dynamic - Air - Remove Cycles) Temperature of 134°C with a minimum autoclave cycle of 5 minutes and a drying cycle of 20 minutes. c. Storage After sterilisation, the product must remain in the sterilisation bags. The bags should only be opened immediately prior to reuse. In normal conditions, sterilisation bags maintain the sterility of the contents, unless the wrapping is damaged. Therefore, do not use components if the bags in which they were kept are damaged, and resterilise in new bags before using them again. The storage time of products sterilised inside the bags should not exceed that recommended by the manufacturer of the bags. The product must be stored in a cool dry place, away from sunlight, water and sources of heat.

41 SURGICAL INSTRUMENTS

Cleaning, disinfection, sterilization and storage of the dynamometric key CRI5-KIT

The processes described below must be performed before use and before each subsequent operation. Repetition of the processes described in this paragraph has minimal effect on the wear of the device. The failure to follow these instructions may cause cross-infections. Containers and transport to be used for washing: there are no special requirements. As soon as possible after each use, the key must be placed in a container filled with a disinfecting/cleansing solution and covered with a cloth. This prevents the desiccation of the contaminating agents coming from the patient, and dissolves them, thus making cleaning easier and more effective. Completely disassemble the key as shown below:

Completely unscrew the torque Use the hexagon tip at the bottom of the After removing the cover, pull out the two adjustment screw and remove the spring torque adjustment screw to unscrew and components contained inside the ratchet inside the handle of the ratchet body. completely remove the connecting screw head: the toothed pawl wheel and wheel Do not separate the spring from the pin of the cover from the side marked “OUT”. stop tooth. that acts as a stop. Exert a light pressure in order to avoid damaging the hexagon tip.

In case of manual cleaning, clean the outer and inner surfaces of the instrument mechanically under hot water with a soft bristled brush. Inject hot water using a needleless syringe to wash the hard-to-access holes of the head and the area around the pawl wheel and wheel stop. If necessary, proceed in the same way for the inside of the handle and of the torque adjustment device. Use a suitable neutral detergent and follow the manufacturer’s user instructions. Use the brush to apply the detergent to all surfaces. Rinse with distilled water for at least four minutes. Make sure the running water passes abundantly through the passages. In case of automated ultrasound cleaning: use an ultrasound bath with a suitable detergent solution. Use neutral detergents only. Follow the manufacturer’s instructions concerning concentrations and washing times. Use demineralised water to prevent the formation of stains and marks. During this cycle, avoid contact between the pieces because this causes the machined surfaces to deteriorate, and consequently, loss of precision of the torque measurement. When draining, check the recesses of the devices, holes, etc. to make sure all residues have been completely removed. If necessary, repeat the cycle or clean manually. Observation: blood residues or other deposits reduce the efficacy of the sterilisation process, which is why it is important to clean thoroughly. During cleaning, avoid sprays or jets of liquid and adopt adequate protections. Avoid contact between this instrument and other nickel-plated instruments.

The pieces must be reassembled prior to sterilisation. Dry the parts, lubricate the functional areas lightly and reassemble the key as shown in the figures. Too much lubrication may cause the surfaces of the instrument to resurface during sterilisation. Use only the lubricant supplied.

42 SURGICAL INSTRUMENTS

After lubricating the parts shown in the fugure, insert Lubricate the contact areas between the tooth of the the two elements of the ratchet head acording to the pawl wheel and the pin of the wheel stop tooth. following sequence: the toothed pawl wheel and then the wheel stop tooth.

Once parts 2 and 3 have been lubricated and inserted in Lubricate the spring inside the ratchet handle as shown the head of the ratchet body, position the cover and turn in the figure. Assemble the torque adjustment screw, the ratchet body from the “OUT”. Tighten the screw with making sure the instrument functions properly. Manually hexagon tip of the torque adjustment screw. activate the pawl wheel.

Sterilization In a vacuum autoclave, proceeding as follows: - Autoclave Temperature = 121 ÷ 124°C, with a minimum autoclave cycle of 20 minutes and a drying cycle of 15 minutes.

This procedure is important in order to preserve the precision of the instrument within a tolerance of ± 3.5 Ncm. Operate the torque and insertion mechanism to check their proper functioning. Remove any traces of lubricant from the outer surface of the key. Place the device in suitable sterilisation bags. It is recommended to practice the disassembly and reassembly operations, following the instructions.

43 SURGICAL SEQUENCES

Preparation of the implant site

To obtain a three-dimensional view of the bone available, it is recommended to lift a mucoperiosteal flap. As already mentioned, pre-operative clinical and radiographic exams play an important role in determining the position and direction according to which the implants will be positioned; in this stage, a surgical stent will be helpful, acting as a guide during the marking of the cortical bone with the precision drill and in the drilling phase with the 2.00 mm pilot drill. As a rule a distance of 3.00 mm should be maintained between the perimeter of the implants, and at least 2.00 mm between implants and adjacent natural teeth. The numerous experimental and clinical studies carried out indicate that it is opportune to position the implants more in a lingual or a palatal direction to obtain the best aesthetic results, because this position helps preserve the level of the hard and soft tissues at the crown of the implant. It is also essential to check that the thickness of the residual bone wall at buccal level is not less than 1.00 mm. The best aesthetic results are obtained with buccal walls of no less than 2.00 mm. If the thickness is smaller there is a high risk of bone reabsorption failure and exposure of the spires.

3.00 mm 2.00 mm

Surgical sequences

The following pages contain information on the drilling sequences for the adequate preparation of all implant types. These procedures come from clinical experience and recommendations taken from numerous studies and clinical protocols for implants of this type. However, it should be remembered that bone types with different densities require different surgical approaches, and the indications below cannot replace the necessary training and knowledge of the doctors, nor their personal experience, which can at times lead to different solutions and indications. The sequences that follow refer to specific bone types. In expansion techniques or in case of regenerative surgery, or when you want to increase the compaction in poor quality bone, the use of drills can be replaced with the relative osteotomes. Remember to always use drills with stops correctly inserted. Remember that the drills always prepare a hole that is longer than the implant. For the overpreparation dimensions, refer to page 20 for the pilot drill and page 23 for the final drills. The preparations must be non-traumatic and as gradual as possible, and must be executed quickly and precisely. No overheating of the bone should be generated. It should also be remembered to initially set the surgical micromotor with the correct torque, reduction and rotation values depending on the operation to be performed. In particular, drills must be used at the speed indicated in each sequence, with the maximum torque and irrigated copiously with cold sterile physiological solution, better if cooled in a refrigerator.

44 SURGICAL SEQUENCES

Incorrect insertion of the instruments in the handpiece will cause instrument vibration, eccentric rotation, early wear and shaft buckling. Suitable surgical micromotors only should be used. Micromotors should be checked regularly by their manufacturers, according to the indications given by the same, to prevent potential malfunctions (e.g. axle shifts for transmission shafts, worn or faulty forceps, etc.). Failure to follow the instructions provided may cause surgical problems and damage to the patient’s health.

Sweden & Martina distributes Impla6000, a brushless micromotor for for surgical and implant procedures. It perfectly combines reliability, high performances and easy to use procedures. Compact, practical with a basic design, Impla6000 comes with all the requirements for maximum precision and safety.

45 SURGICAL SEQUENCES

Surgical sequence for the insertion of CSR-DAT implants with ø 3.80 mm

The sequence illustrated refers to an implant with ø 3.80 mm and H. 15.00 mm. The use of the stop depends on the clinician. Their use is however recommended, most of all in the case of poor intraoperative visibility. Please remember that the drills overprepare the length for a measurement reported in the table on page 20 (for the pilot drill) and page 23 (for the final drills).

bone crest level

4.80 mm

15.00 mm

overpreparation level

FS-230 CSR-FP-200 CSR-FI-280

BONE D1 1.100 rpm 1.100 rpm 1.100 rpm

BONE D2 1.100 rpm 1.100 rpm 1.100 rpm ø 3.80 mm BONE D3 900 rpm 900 rpm 900 rpm

BONE D4 900 rpm 900 rpm osteotome E-OS-090-PP

Important warning As these drills have a cylindrical shape, the only CSR-FF-320 drill available can be used for the preparation of all the heights of implants with ø 3.80 mm, up to the respective laser-etched mark. It is a advisable to use a depth stop for safe and controlled preparation (see page 24).

46 SURGICAL SEQUENCES

CSR-FF-320 CSR-FC EASYC4-EX230-CA

900 rpm 1.100 rpm 30 rpm

900 rpm 1.100 rpm 30 rpm

900 rpm - 30 rpm

osteotome E-OS-160-PC - 30 rpm

Please note:for implants H. 18.00 mm the preparation must be executed without the stops assistance for the entire lenght of the working part of the drill (in this case the widening at the end of this point works as a security stop).

Important warning Indications are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site. In any case it must be considered the warnings on the lenght overpreparations reported in details of each drill, from page 20.

47 SURGICAL SEQUENCES

Surgical sequence for the insertion of CSR-DAT implants with ø 4.20 mm

The sequence illustrated refers to an implant with ø 4.20 mm and H. 15.00 mm. he use of the stop depends on the clinician. Their use is however recommended, most of all in the case of poor intraoperative visibility. Please remember that the drills overprepare the length for a measurement reported in the table on page 20 (for the pilot drill) and page 23 (for the final drills).

bone crest level

4.80 mm

15.00 mm

overpreparation level

FS-230 CSR-FP-200 CSR-FI-280

BONE D1 1.100 rpm 1.100 rpm 1.100 rpm

BONE D2 1.100 rpm 1.100 rpm 1.100 rpm ø 4.20 mm BONE D3 900 rpm 900 rpm 900 rpm

BONE D4 900 rpm 900 rpm osteotome E-OS-090-PP

Important warning The drills have a cylindrical shape, so they can be used for the preparation of all the heights of implants with ø 4.20 mm, up to the respective laser-etched mark. It is a advisable to use a depth stop for safe and controlled preparation (see page 24).

48 SURGICAL SEQUENCES

CSR-FF-320 CSR-FF-360 CSR-FC EASYC4-EX230-CA

1.100 rpm 900 rpm 1.100 rpm 30 rpm

1.100 rpm 900 rpm 1.100 rpm 30 rpm

900 rpm 900 rpm - 30 rpm

osteotome E-OS-160-PC osteotome E-OS-160-PC - 30 rpm

Please note: for implants H. 18.00 mm the preparation must be executed without the stops assistance for the entire lenght of the working part of the drill (in this case the widening at the end of this point works as a security stop).

Important warning Indications are referred to the iuxtaosseus positioning of the implant. In case it is chosen to insert the implant at a subcrestal level, it is necessary to adeguate the preparation of the surgical site. In any case it must be considered the warnings on the lenght overpreparations reported in details of each drill, from page 20.

49 GENERAL INFORMATION

Insertion of the implant 1 Use the patient label inside the pack for the patient’s medical file, and apply it to the Dental Card. This will make it easier to record the patient’s treatment plan and will keep a trace of the product batch used.

Dental

CardCertificato di Originalità e Assistenza

2 Open the blister pack and place the vial inside it on a sterile surface (e.g. on a disposable towel or a sterile cloth) next to the operating area.

Cap of the surgical cover screw recess

Surgical cover screw

Blue vial cap in LDPE containing the surgical cover screw

Implant

Implant carrying basket

Vial

3 Immediately before the insertion into the oral cavity, remove the blue cap of the vial, making sure not to remove the transparent cap containing the surgical cover screw. The implant holding cylinder inside the vial and the surgical cover screw are coloured according to a colour code that allows the rapid identification of the implant diameter.

50 GENERAL INFORMATION

Standard procedure

When the vial is opened, the implant is exposed with the connection ready to be engaged. The implant can be picked up with the Easy Insert driver and then screwed mechanically in situ with the aid of a suitable surgical micromotor with torque control set at a screwing speed of 30 rpm and a maximum torque of 70 Ncm. The driver has been tested up to 70 Ncm without showing signs of deformations or failures. Both mechanical and manual instruments with torque control must be calibrated regularly using a suitable calibration device.

After implant insertion

Healing times It is essential to respect the healing times recommended in implant surgery, and periodically checking the progress of osseointegration with x-rays. The preliminary healing times of an implant are influenced by the quality of the receiving bone. In the case of immediate load, consider the warnings reported on page 7. If deferred loading is chosen, temporary mobile prostheses must be used prudently, with a correct distribution of their load, to reduce discomfort during the biological times necessary for osseointegration.

After healing is completed, the surgical cover screws of the implants must be removed. If the right angle driver is used, the surgical micromotor must be set with the following parameters: 20 rpm and torque 10 Ncm. Subsequently, depending on the protocol adopted, tissue profiles must be adapted using a suitable temporary fitting or healing abutments. It is recommended to secure the healing abutments manually or with a torque no greater than 10 Ncm.

51 GENERAL INFORMATION

Intraoperative removal of implants if necessary

If a previously inserted implant needs to be removed, this can be done by directly engaging the hexagonal driver connection of the implant. Accurately clean any blood and residue produced during insertion from the well of the implant, take the driver BC-EX230 from the surgical kit, insert the hexagonal part of the driver inside the implant making sure the instrument is in axis with the implant and that the internal connection is engaged completely and deeply; now block the head of the torque wrench (or the ratchet) and connect it to the hexagonal part of the driver, making sure the laser-etched arrow on the ratchet head indicates the counter clockwise direction and prise it up while keeping the driver/ratchet assembly in axis with your index finger.

Maintenance of the prosthesis

Some implant restoration-related complications are reported in the literature. These complications may lead to a loss of osseointegration and implant failure. Correct maintenance by the patient, satisfactory home dental hygiene and regular sessions with a professional hygienist increase the device service life. Complications such as the unscrewing of the screws securing the prostheses to implants or bone reabsorption causing the loss of the gingival support surface in the case of removable prostheses can be easily prevented with regular check-ups. If post or prostheses screws need to be tightened, this must be done by the practitioner, using suitable instruments with control over tightening torque. The calibration of these instrument should be checked regularly. In the event of complications of this kind, patients should contact their practitioner as soon as possible, so that the necessary work to restore correct orthodontic functionality can be carried out. Delays in consulting the practitioner may lead firstly to the fracture of the connection screw or of the prosthesis, and secondly to the loss of the implant, thereby compromising rehabilitation results. Practitioners must make this clear to their patients. Complications may be biological (impaired integration) or mechanical (fracture of a component due to excessive loads). If there are no complications, duration depends on the devices and the whole restoration system depends on mechanical resistance in relation to the fatigue accumulated by the device. Responsibility for defective products and warranty terms

Optimal patient care and attention to their needs are necessary conditions for the success of implantation procedures and, therefore, patients must be carefully selected and informed of the associated risks and obligations connected with the treatment and encouraged to cooperate with the in the interests of the success of the same treatment. The patient must, therefore, maintain good hygiene, which should be confirmed during check-up appointments, guaranteed and recorded and the practitioners instructions and orders shall be observed. The warranty only covers manufacturing defects as long as the faulty piece is identified by the article code and batch number and returned within the validity period of the warranty. The warranty terms are available on the website www.sweden-martina.com. Disposal

If removed from the oral cavity due to biological or mechanical failure, the implant fixtures must be disposed of as biological waste. The surgical instruments are made of small components, mostly metal. They may therefore be disposed of as metal wastes. If dirty, they must be disposed of as biological wastes. In general, the local regulations apply. 52 GENERAL INFORMATION

Composition of the materials

The materials used for manufacturing the surgical instruments illustrated in this manual were selected based on the properties indicated for their intended use according to directive 93/42, implemented in Italy with Law 46/97, Annex I – Essential Requirements, point 7.1.

Implants The implants are made of Gr. 4 commercially pure titanium, in compliance with harmonized standards. Although very rare, titanium allergy is possible. Patients should therefore always be asked whether they have allergies of this type. The characteristics of the Gr. 4 titanium used are listed below.

Grade 4 titanium (Cold worked)* ASTM F67-13, ISO 5832-2:2012

chemical composition maximum allowed values (%) tolerance

nitrogen 0.05 +/- 0.02

carbon 0 .10 +/- 0.02

hydrogen 0.015 +/- 0.002

iron 0.25 +/- 0.10 (%<0.25) +/- 0.15 (%>0.25)

oxygen 0.20 +/- 0.02 (%<0.20) +/- 0.03 (%>0.20)

titanium remainder -

* This technical information complies with the express specifications of the regulations in force on the use of Gr. 4 titanium in implantology: • ASTM F67-13: Standard Specification for unalloyed titanium, for surgical implant applications. • ISO 5832-2: 2012: Implants for surgery – Metallic materials – Part 2: Unalloyed titanium.

Please note: the use of cold worked Gr. 4 titanium bars for the production of Sweden & Martina implants allows the exploitation of mechanical characteristics higher than those required by applicable standards. Furthermore, the excellent results documented during 20 years of clinical experience corroborate the choice of the coldworking production process and of ZirTi surface treatments, which express and enhance the raw material potential selected by Sweden & Martina.

Surgical instruments Depending on the type of component, surgical instruments are made of: • Gr. 5 titanium • 1.4197 steel • 1.4542 steel • 1.4305 (AISI 630) steel • 1.4108 (AISI 303) steel • 1.4108 steel • 1.4112 steel

Patients must be asked if they are allergic to any of the materials used.

53 GENERAL INFORMATION

Identification of the manufacturer

The manufacturer of CSR-DAT implants and of the respective surgical instruments is:

Sweden & Martina Via Veneto 10 - 35020 Due Carrare (Padua) - Italy Tel. +39 049.9124300 - Fax + 39 049.9124290 e-mail: [email protected] www.sweden-martina.com

In accordance with Directive 93/42/EEC implemented in Italy with L.D. 46/97 of 26/03/97, Annex IX, Sweden & Martina identifies the risk class of these products as indicated in Table 01. Even though they can be used with all patients who have suitable therapeutic indications, dental implants and the respective surgical instruments must be used only by professional or surgeons with the necessary qualifications and training.

Table 01 - Risk classes

device directive 93/42/EEC packing rule risk Annex IX class

Implant fixtures for dental Implantable devices intended for Single-use sterile pack, fixture 8 IIb use belonging to the long-term use (over 30 days) complete with surgical cover CSR-DAT implant system screw

Surgical cover screws Implantable devices intended for Sold in packs complete with 8 IIb long-term use (over 30 days)) the respective fixtures or sold individually (single-use sterile pack)

Complete surgical kits Re-usable surgical instruments Sold in NON-STERILE packs 6 IIa

Radel instrument tray and Non invasive medical devices Sold in NON-STERILE packs 1 I X-ray templates

Surgical drills (precision, final, Re-usable invasive surgical Sold in NON-STERILE packs 6 IIa for distal use); extension for instruments for temporary use drills; stops for drills; drivers (for less than 60 minutes at a and screwdrivers intended for time) use with a micromotor

Osteotomes/bone expanders; Re-usable invasive surgical Sold in NON-STERILE packs 6 I screwdrivers; manual and instruments for temporary digital drivers, hand knob, use (for less than 60 minutes depth gauges, parallelism pins at a time), not intended to be and cylinders for stents connected to an active medical device

54 GENERAL INFORMATION

Key to symbols used on the implant packs:

description symbol

Caution! See instructions for use

Batch number

Code

Manufacturer

Consult instructions for use 0476

CE conformity mark for class IIa/IIb products 0476 American federal law restricts this device to sale by or by order of a professional practitioner

Do not resterilize

Single use product, do not reuse

Do not use if the packaging is damaged

Sterile device, sterilization by radiation

Expiry date

Key to symbols used on surgical instrument packs:

description symbol

Caution! See instructions for use

Batch number

Code

Manufacturer

Consult instructions for use 0476

CE conformity mark for class IIa/IIb products 0476 CE conformity mark for class I products

American federal law restricts this device to sale by or by order of a professional practitioner

NO-STERILE device

55 GENERAL INFORMATION

Key to symbols used on prosthesis packs:

description symbol

Caution! See instructions for use

Batch number

Code

Manufacturer

Consult instructions for use 0476

CE conformity mark for class IIa/IIb products 0476 CE conformity mark for class I products

American federal law restricts this device to sale by or by order of a professional practitioner

Single product use, do not reuse

NO-STERILE device

THIS MANUAL WAS LAST UPDATED IN JULY 2016.

The medical devices contained in this manual have been designed and manufactured in accordance with the most recent directives and harmonized standards applicable to the materials used, the production processes, the sterilization, the information supplied and the packaging.

56 BIBLIOGRAPHY ON SWEDEN & MARTINA IMPLANTS SINCE 2013

Bibliography on Sweden & Martina implants since 2013 -Gandolfi M.G., Siboni F., Piattelli A., Prati C.; Nano-topography, micro- zando la técnica B.O.P.T. ,Numeri Uno 2015; 04:11-14 chemical properties and calcium phosphates nucleation of premium -Agustín Panadero R., Serra Pastor B., Roig Vanaclocha A., Román implant surfaces; 30th Annual Congress, American Academy of Osseoin- Rodriguez J.L., Fons Font A.; Mechanical behavior of provisional implant tegration, San Francisco, 12-14 March 2015, Poster Id 2088727 prosthetic abutments; Medicina Oral, Patología Oral y Cirugía Bucal -Caneva M., Lang N.P., Calvo Guirado J.L., Spriano A.M., Iezzi G., Bot- 2015; 20(1):e94-102 ticelli D.; Bone healing at bicortically installed implants with different -Crespi R., Capparè P., Polizzi E.M., Gherlone E.F. ; Tissue remodeling surface configurations. an experimental study in rabbits; Clinical Oral after bone expansion in grafted and ungrafted sockets Implant Research, 2015; 26:293–299 The International Journal of Oral & Maxillofacial Implants, 2014;29:699- doi: 10.1111/clr.12475 704; doi: 10.11607/jomi.3535 - Beolchini M, Lang N.P., Gomez Moreno G., Iezzi G., Botticelli D., Calvo -Negri B., López Marí M., Maté Sánchez de Val J.E., Iezzi G., Bravo Gon- Guirado J.L.; Bone healing at implants with different surface configu- zález L.A., Calvo Guirado J.L.; Biological width formation to immediate rations: an experimental study in dogs, Clinical Oral Implant Research, implants placed at different level in relation to the crestal bone: an 2015; 00:1–7, doi: 10.1111/clr.12562 experimental study in dogs; Clinical Oral Implant Research, 2014; 00:1-11 -Baffone G., Lang N.P., Pantani F., Favero G., Ferri M., Botticelli D.; Hard ;doi: 10.1111/clr.12345 and soft tissue changes around implants installed in regular-sized and -Esposito M., Ardebili Y., Worthington H.V.;Interventions for replacing reduced alveolar bony ridges. An experimental study in dogs. Clinical missing teeth: different types of dental implants (review); Cochrane Oral Implant Research, 2015; 26:96-101; doi: 10.1111/clr.12306 database of systematic reviews, 2014:22;7; doi: 10.1002/14651858. -Bengazi F., Lang N.P., Caroprese M., Velez J.U., Favero V., Botticelli D.; CD003815.pub4. Dimensional changes in soft tissues around dental implants following -Canullo L., Peñarrocha Oltra D., Peñarrocha Diago M., Rocio A.G., free gingival grafting: an experimental study in dogs; Clinical Oral Im- Peñarrocha Diago M.A.; Piezoelectric vs. conventional drilling in implant plant Research, 2015; 26:176-82; doi: 10.1111/clr.12280 site preparation: pilot controlled randomized clinical trial with crossover -Morelli F., Lang N.P., Bengazi F., Baffone D., Vila Morales C.D., Botticelli design; Clinical Oral Implants Research 2014; 25:1336-43; doi: 10.1111/ D.; Influence of bone marrow on osseointegration in long bones: an expe- clr.12278 rimental study in sheep; Clinical Oral Implant Research, 2015; 26:300- -Lumetti S., Di Blasio A., Manfredi E., Ghiacci G., Toffoli A., Bonanini M., 306; doi: 10.1111/clr.12487 Macaluso G.M., Galli C.;Implant surface microtopography affects cell -Mainetti T., Lang N., Bengazi F., Sbricoli L., Soto Cantero L., Botticelli D.; the pattern of cell growth, cell-to-cell contacts and the expression of Immediate loading of implants installed in a healed alveolar bony ridge connexin 43; Clinical Oral Implant Research, 2014; 25 Suppl 10:222 or immediately after tooth extraction: an experimental study in dogs; -Negri M., Galli C., Smerieri A., Macaluso G.M., Manfredi E., Ghiacci G., Clinical Oral Implant Research, 2015; 26:435-441; doi: 10.1111/clr.12389 Toffoli A., Bonanini M., Lumetti S.;The effect of age, gender and insertion -Borgia V., Alfonsi F., Toti P., Tonelli P., Covani U., Barone A.; Immediate site on marginal bone loss around endosseous implants: results from a restoration of post-extraction implants. a 7 years prospective single 3-year trial with premium implant system; BioMed research Internatio- cohort study; 30th Annual Congress, American Academy of Osseointe- nal, 2014; Article ID 369051: 7; doi.org/10.1155/2014/369051 gration, San Francisco, 12-14 March 2015, Poster -Quaranta A., Andreana S., Pompa G., Procaccini M.; Active implant pe- -Guazzotti P.P.;Carico immediato di impianti post estrattivi: presentazio- ri-apical lesion: a case report treated via guided bone regeneration with ne di un caso clinico full-arch; Doctor OS, 2015; XXVI, 01 a 5-year clinical and radiographic follow-up ; Journal of Oral Implantolo- -Agustín Panadero R., Serra Pastor B., Chust López C., Fons Font A., gy 2014;40:313-319; doi: 10.1563/AAID-JOI-D-11-00214 Ferreiroa A.; Immediate placement of single implant simultaneously with -Bowen Antolín A., Ariño B., Arlandi Garrido M.; Regeneración ósea immediate loading in a fresh socket associated to periapical infection: periimplantaria con fosfato de calcio bifásico y ácido poliláctico; Gaceta a clinical case report; Journal of Clinical and Experimental Dental, 2014, 260(7): 174-186 2015;7(1):e175-9 -Mainetti T., Lang N.P., Bengazi F., Favero V., Soto Cantero L., Botticelli -Crespi R., Bruschi G. B., Gastaldi G., Capparè P., Gherlone E.F.; Imme- D.;Sequential healing at implants installed immediately into extraction diate loaded implants in split-crest procedure; Clinical Implant Dentistry sockets. An experimental study in dogs; Clinical Oral Implant Research, and Related Research, Article first published online: 17 MAR 2015; DOI: 2014; 00:1-9; doi: 10.1111/clr.12533 10.1111/cid.12316 -Covani U., Marconcini S., Ferrini F., Gelpi F., Finotti M., Barone A.; -Peñarrocha Oltra D., Covani U., Peñarrocha Diago M., Peñarrocha Post-traumatic use of dental implants immediately after tooth Diago M.A.; Immediate versus conventional loading with fixed full-arch extraction - clinical study, The Journal of Craniofacial Surgery, 2014; prostheses in mandibles with failing dentition: a prospective control- 25:796-798; doi 10,1097/SCS.0000000000000522 led study; The International Journal of Oral & Maxillofacial Implants -Engelhardt S., Papacosta S., Rathe F., Ozen J., Jansen J.A., Junker R.; 2015;30:427–434; doi: 10.11607/jomi.3534 Annual failure rates and marginal bone-level changes of immediate -Canullo L., Peñarrocha Oltra D., Covani U., Botticelli D., Serino G., compared to conventional loading of dental implants. a systematic re- Peñarrocha Diago M.; Clinical and microbiological findings in patients view of the literature and meta-analysis; Clinical Oral Implants Research with peri-implantitis: a cross-sectional study; Clinical Oral Implants 2014;00:1–17; doi: 10.1111/clr.12363 Research 2015; 00:1-7; doi: 10.1111/clr.12557 -Romanos G.R., Javed F.; Platform switching minimises crestal bone -Requena Gómez E., Cervantes Haro M.N., Aragoneses Lamas J.M.; ¿Es loss around dental implants: truth or myth? la cirugía guiada junto a la carga inmediata una técnica predecible? a Journal of Oral Rehabilitation, 2014; 41:700-708; doi: 10.1111/joor.12189 propósito de un caso clínico; Numeri Uno 2015; 04: 16-19 -Strietzel F.P., Neumann K., Hertel M.; Review article: impact of platform -Peñarrocha Oltra D., Covani U., Peñarrocha Diago M., Peñarrocha switching on marginal peri-implant bone-level changes. a systematic Diago M.A.; Immediate versus conventional loading for the maxilla with review and meta-analysis. Clinical Oral Implant Research, 2014; 00:1-16; implants placed into fresh and healed extraction sites to support a doi: 10.1111/clr.12339 full-arch fixed prosthesis: nonrandomized controlled clinical study; The -Kinaia B.M., Shah M., Neely A.L., Goodies H.E.; Crestal bone level International Journal of Oral & Maxillofacial Implants 2015;30:427–434; changes around immediately placed implants: a systematic review doi: 10.11607/jomi.3534 and meta-analyses with at least 12 months’ follow-up after functional -Bruschi G.B., Crespi R., Capparè P., Grande N., Bruschi E., Gherlone E.; loading; Journal of , 2014; 85:1537-48; doi: 10.1902/ Radiographic evaluation of crestal bone levels of delayed implants at jop.2014.130722. Epub 2014 May 2 medium-term follow-up; The International Journal of Oral & Maxillofacial -Covani U., Canullo L., Toti P., Alfonsi F., Barone A.; Tissue stability Implants 2014;29:441-447 of implants placed in fresh extraction sockets: a 5-year prospective doi: 10.11607/jomi.3254 single-cohort study ; Journal of Periodontology, 2014; 85:e323-332; doi: -Prati C., Zamparini F., Ciulla A., Buonavoglia A., Gatto M.R., Piattelli A., 10.1902/jop.2014.140175. Epub 2014 May 16. Gandolfi M.G.; Evaluation of marginal bone level of premium implants; -D’Ercole S., Tripodi D., Marzo G., Bernardi S., Continenza M.A., Piat- IADR General Session, Boston 11-14 Marzo 2015, Poster telli A., Iaculli F., Mummolo S.; Microleakage of bacteria in different -Canullo L., Peñarrocha Oltra D., Soldini C., Mazzocco F., Peñarrocha Dia- implant-abutment assemblies: an in vitro study ; Journal of Applied Bio- go M., Covani U.; Microbiological assessment of the implant-abutment material and Functional Materials, 2014, accepted June 12; doi: 105301/ interface in different connections: cross-sectional study after 5 years jabfm.5000214 of functional loading; Clinical Oral Implantology, 2015; 26:426-434, doi: -Peñarrocha Oltra D., Rossetti P.H., Covani U., Galluccio F., Canullo L.; 10.1111/clr.12383 Microbial leakage at the implant/abutment connection due to implant -Kern J.S., Kern T., Wolfart S., Heussen N.; Review - a systematic review insertion maneuvers: cross-sectional study 5 years post loading in heal- and meta-analysis of removable and fixed implant-supported prosthe- thy patients; Journal of Oral Implantology, 2014; 23 [Epub ahead of print] ses in edentulous jaws: post-loading implant loss; Clinical Oral Implants -Maiorana C., Farronato D., Pieroni S., Cicciù M., Andreoni D., Santoro F.; Research 2015; 00:1–22 ; doi: 10.1111/clr.12531 A four-year survival rate multicenter prospective clinical study on 377 -Martín Anciburo M.A.; Rehabilitación unitaria implantosoportada utili- implants: correlations between implant insertion torque, diameter and 57 BIBLIOGRAFIA RELATIVA AGLI IMPIANTI SWEDEN & MARTINA DAL 2013

bone quality; Journal of Oral Implantology 2014;11 [Epub ahead of print] carico immediato; Italian Dental Journal 2014; 29, agosto -Crespi R., Bruschi G.B., Capparè P., Gherlone E.; The utility of the -Gaspari L.; Implantoprotesi conometrica elettrosaldata chairside a electric mallet; The Journal of Craniofacial Surgery, 2014;25,793-795; doi carico immediato - caso clinico; Numeri Uno 2014;18:12-14 10,1097/SCS.0000000000000523 -Pradíes Ramiro G., Abad Coronel C., García Martínez I., Ferreiroa Na- -Schirripa G., Schirripa F.; Carico immediato; Numeri Uno, 2014, 19, varro A.; Impresiones fiables: dos propuestas para un mismo objetivo; 22-24 Numeri Uno 2014; 01:6-9 -Csonka M.; Trattamento implantologico delle creste sottili: split crest o -Beolchini M., Lang N.L., Ricci E., Bengazi F., Garcia Triana B., Botticelli gbr? ; Numeri Uno, 19: 12-14, 2014 D.; Influence on alveolar resorption of the buccal bony plate width in the -Machín Muñiz A.; Regeneración ósea y gingival en implantes inmediatos edentulous ridge expansion (e.r.e.) – an experimental study in the dog; post-extracción; Numeri Uno 2014; 01: 20-21 Clinical Oral Implant Research, 2013; 00:1–6 ;doi: 10.1111/clr.12308 -Peñarrocha Oltra D., Peñarrocha Diago M.A., Canullo L., Covani U., -Petrillo N.; Carico immediato full-arch mascellare e mandibolare: Peñarrocha Diago M.; Patient-reported outcomes of immediate versus un nuovo approccio chirurgico e protesico; Il Dentista Moderno, 2013, conventional loading with fixed full-arch prostheses in the maxilla: a Novembre: 82-96 nonrandomized controlled prospective study; The International Jour- -Sisti A., Mottola M.P., Mottola P.;Riabilitazione bilaterale con chirurgia nal of Oral & Maxillofacial Implants, 2014;29:690-698; doi: 10.11607/ guidata; Numeri Uno, 2013; 16:16-18 jomi.3516 -Ponzi A.; Echoplan: accuracy dell’implantologia guidata; Numeri Uno, -Baldi D., Colombo J., Pera P., Hauschild U.; Una tecnica minimamen- 2013;16:12-13 te invasiva: implantologia con utilizzo di impianti a diametro ridotto e -Morandini E.; La precisione nel cr.co. laser sinterizzato rivestito in cera- tecniche cad cam per una provvisorizzazione a lungo termine; Numeri mica parte 1; NumeriUno, 2013; 17: 9-11 Uno, 2014;18: 6-9 -Figliuzzi M. M., De Fazio R., Tiano R., Scordamaglia F., Fortunato L.; Ria- -Calesini G., Zarone F., Sorrentino R., Micarelli C., Fabianelli A., Papac- bilitazione con impianto post-estrattivo immediato in zona estetica: case chini F., Gherlone E.; Effect of 2 impression techniques on the dimen- report; Numeri Uno, 17, 2013, 21-22 sional accuracy of working implant prosthesis models: an in vitro study; -Canullo L., Cicchese P., Marinotti F.;Riabilitazione implanto-supportata Journal of Craniofacial Surgery 2014;25:822-827 di entrambi i mascellari edentuli con carico immediato; Numeri Uno, -Pellicer Chover H., Peñarrocha Oltra D., Bagán L., Fichy Fernandez A.J., 2013; 16, 14-15 Canullo L., Peñarrocha Diago M.;Single-blind randomized clinical trial to -Beolchini M., Lang N.L., Viganò P., Bengazi F., Triana B.G., Botticelli D.; evaluate clinical and radiological outcomes after one year of immediate The edentulous ridge expansion (ere) technique an experimental study in versus delayed implant placement supporting full-arch prostheses; the dog; Clinical Oral Implant Research, 2013; 25:1207-1211; doi: 10.1111/ Medicina Oral Patología Oral y Cirugía Bucal, 2014; 19: e295-301 clr.12263. Epub 2013 Sep 12 -Morandini E.; La precisione nel cr.co. laser sinterizzato rivestito in cera- -Bengazi F., Botticelli D., Favero V., Perini A., Urbizo Velez J., Lang N.P.; mica parte 2; NumeriUno, 2014;18: 16-19 Influence of presence or absence of keratinized mucosa on the alveolar -De Santis E., Lang N.P., Favero G., Beolchini M., Morelli F., Botticelli D.; bony crest level as it relates to different buccal marginal bone thicknes- Healing at mandibular block-grafted sites. an experimental study in ses. an experimental study in dogs; Clinical Oral Implant Research, 2014; dogs; Clinical Oral Implant Research, 2014; 00:1–7; doi: 10.1111/clr.12434 25:1065-71 ;doi: 10.1111/clr.12233. Epub 2013 Jul 29. -Cocchetto R.; Improved cementation technique for implant restora- -Crespi R., Capparè P., Gherlone E.F.; Electrical mallet in implants placed tions to avoid peri-implant cement remnants: clinical and microscopical in fresh extraction sockets with simultaneous osteotome sinus floor evaluation with two different abutment design; Clinical Oral Implants elevation; The International Journal of Oral & Maxillofacial Implants Research 2014; 25(Suppl. 10); Doi 10.1111 clr.12458_94 2013;28:869-874; doi: 10.11607/jomi.2679 -J. Viña Almunia; Microbial colonization of the implant connection with -Crespi R., Capparè P., Gherlone E.F.; Electrical mallet provides essential cemented versus screw-retained suprastructures advantages in split-crest and immediate implant placement; Internatio- Clinical Oral Implants Research, 2014; 25; DOI 10.1111/clr.12458_91 nal Journal of Oral and Maxillofacial Surgery 2014;18:59-64; doi: 10.1007/ -Cicciù M., Bramanti E., Matacena G., Guglielmino E., Risitano G.; Fem s10006-013-0389-2. Epub 2013 Jan 18 evaluation of cemented-retained versus screw-retained -Csonka M.; Split crest di una cresta molto sottile con il magnetic mallet; single-tooth crown prosthesis ; International Journal of Clinical and Numeri Uno, 2013,16:22-23 Experimental Medicine 2014; 7(4):817-825 -Calesini G., Scipioni A.; Approccio rigenerativo sistematico finalizzato -Vischia F., Roncoroni F.; Ortodonzia protesica mediante tecnica B.O.P.T. ; all’integrazione morfo-funzionale in implantoprotesi Numeri Uno, 2014;19:19-21 Numeri Uno, 16: 6-9, 2013 -Loi I.; Tecnica B.O.P.T. su denti e impianti per la riabilitazione di un’arca- -Bressan E., Lang N.P., Corazza B., Rizzi S., Almagro Urrutia Z., Botticelli ta completa; Numeri Uno, 2014;18:21-22 D.; The platform switching concept revisited. an experimental study in -Vedove F., Riabilitazione di elemento singolo in zona estetica con im- dogs. Clinical Oral Implant Research, 2013; 00:1-7; doi: 10.1111/clr.12262 pianto Prama; Numeri Uno, 2014;20:18-19 -Corrente G., Abundo R., Greppi M., Perelli M., Villa A.; Posizionamento -Gorni F.; Riabilitazione di elemento singolo in zona estetica con impian- implantare e ricostruzione dei tessuti duri e molli: un protocollo semplifi- to Prama RF; Numeri Uno, 2014;20:16-17 cato ; Numeri Uno, 2013, 17:14-17 -Andreoni D.; Riabilitazione di elemento singolo in posizione 4.6 con -Guidi R., Viscioni A., Dattola F., Carinci F.; Dental implants inserted in na- impianto Prama; Numeri Uno, 2014; 20: 20-21 tive bone: cases series analyses.; Dental Research Journal 2012;9:s175- -Sandri L.P.; Utilizzo clinico dei nuovi impianti Prama: inserimento e 180; doi: 10.4103/1735-3327.109747 riabilitazione con un singolo impianto; Numeri Uno 2014; 20:22-24 -Canullo L., Cicchese P., Marinotti F.; Valutazione di una procedura clinica -Loi I.; Riabilitazione implanto-protesica di elemento incisivo frontale e tecnica per la riabilitazione di mascellari edentuli; Il dentista moderno, con impianto Prama; Numeri Uno, 2014; 20:12-13 2012; Marzo: 86-102 -Loi I.; Riabilitazione implantoprotesica di ponte distale con impianti -Covani U., Ricci M., Tonelli P., Barone A.; An evaluation of new designs Prama ;Numeri Uno, 2014; 20:14-15 in implant-abutment connections: a finite element method asses- -Canullo L., Peñarrocha Oltra D., Marchionni S., Bagán L., Peñarrocha sment; Implant Dentistry / volume 22, Number 3 2013; DOI: 10.1097/ Diago M.A., Micarelli C.; Soft tissue cell adhesion to titanium abut- ID.0b013e318292625f ments after different cleaning procedures: preliminary results of a -Micarelli C., Canullo L., Grusovin M.G., Peñarrocha Oltra D.; Cell adhesion randomized clinical trial; Medicina Oral, Patología Oral y Cirugía Bucal to titanium abutments after different cleaning procedures; Clinical Oral 2014;19(2):e177-83 Implants Research 2013;24,79–102 (Suppl. 9); doi: 10.11607/jomi.2664 -Canullo L., Micarelli C., Bettazzoni L., Magnelli A., Baldissara P.; Shear -Canullo L., Peñarrocha Oltra D., Covani U., Micarelli C., Massidda O.; bond strength of veneering porcelain to zirconia after argon plasma Hard tissue response to plasma of argon cleaning treatment on titanium treatment; The International Journal of 2014;27(2):137- abutments: 2-year follow-up rct; Clinical Oral Implants Research 2013; 139; doi: 10.11607/ijp.3722 24:27-47 (Suppl. 9) -Canullo L., Micarelli C., Bettazzoni L., Koçi B., Baldissara P.; Zirco- -Canullo L., Peñarrocha Oltra D., Micarelli C., Massidda O., Bazzoli M.; nia-composite bonding after plasma of argon treatment; The Internatio- Risposta dei tessuti duri alla pulizia con plasma di argon/sterilizzazione nal Journal of Prosthodontics 2014; 27:267-269; doi: 10.11607/ijp.3686 di pilastri in titanio individualizzati, vs pulizia di 5 secondi con vapore: -Marchetti E., Ratta S., Mummolo S., Tecco S., Pecci R., Bedini R., Marzo risultati di un studio controllato randomizzato in pazienti con una situa- G.; Evaluation of an endosseus oral implant system according to uni en zione parodontale favorevole con follow-up a 2 anni dal carico; European iso 14801 fatigue test protocol; Implant Dentistry, 2014, Early View in Journal of Oral Implantology 2013;6(3):251-60 ahead of print; doi: 10.1097/id.151 -Canullo L., Peñarrocha Oltra D., Clementini M., Iannello G., Micarelli -Crespi R., Capparè P., Gastaldi G., Gherlone E.F.; Immediate occlusal C.;impact of plasma of argon cleaning treatment on implant abutmen- loading of full-arch rehabilitations: screw-retained versus cement-re- ts in patients with a history of periodontal disease and thin biotype: tained prosthesis. an 8 year clinical evaluation; International Journal of radiographic results at 24-month follow-up of a rct; Clinical Oral Implants Oral & Maxillofacial Implants 2014;29:1406-1411; doi: 10.11607/jomi.3746 Research 2015;26(1):8-14; doi: 10.1111/clr.12290. Epub 2013 Nov 6 -Peñarrocha Oltra D., Candel Martí M.E., Peñarrocha Diago M., Agu- -Canullo L., Cassinelli C., Götz W., Tarnow D.; Plasma of argon accelerates stín-Panadero R., Canullo L., Peñarrocha Diago M.A.; The horizontal murine fibroblast adhesion in early stages of titanium disk colonization; denture: a prosthodontic alternative for patients with severe maxillary The International Journal of Oral & Maxillofacial Implants 2013;28(4):957- atrophy. a technical note; Journal of Oral Implantology 2014; 8 [Epub 62; doi: 10.11607/jomi.2664 ahead of print] -Avellino W., De Maria A., Milan U., Tamagnone L., Delle Rose D.; Direct 58 -Gaspari L.; Tecnica conometrica con provvisorio elettrosaldato per prosthetic framework (D.P.F.) BIBLIOGRAFIA RELATIVA AGLI IMPIANTI SWEDEN & MARTINA DAL 2013

Numeri Uno, 2013; 17:18-20 placed at different levels in relation to the crestal bone - an experimen- -Agustín Panadero R., Fons Font A., Román Rodríguez J.L., Solá Ruíz M.F., tal study in dogs; Clinical Oral Implant Research, 00, 2014: 1-11, Early Cebriá J.R.; Sobredentadura implantosoportada de inserción horizontal; view in ahead of print, accepted 06 January 2014 doi 10.1111/clr.12345, Gaceta Dental 249, 2013; 100-112 -Strietzel FP, Neumann K, Hertel M ; Impact of platform switching on -Sandri L.P.; Preparazione protesica mediante tecnica B.O.P.T.: caso marginal peri-implant bone-level changes. A systematic review and clinico; Numeri Uno, 2013;17:6-8 meta-analysis; Clinical Oral Implant Research, 00, 2014: 1-16, Early view -Canullo L., Cicchese P., Marinotti F., Sisti A.; Strategia protesica in ahead of print, accepted 11 December 2013, doi 10.1111/clr.123339 minimamente invasiva negli impianti post-estrattivi: posizionamento e -Peñarrocha-Oltra D, Candel-Marti E, Peñarrocha-Diago M, Augu- avvitamento; Il Dentista Moderno, 2011, Dicembre: 46-54 stín-Panadero R, Canullo L, Peñarrocha M; The Horizontal Denture©: a -Bengazi F, Lang NP, Caroprese M, Velez JU, Favero V, Botticelli D; Dimen- prosthodontic alternative for Severe Maxillary Atrophy. A technical note; sional changes in soft tissues around dental implants following free gingi- Journal of Oral Implantology, Early view in ahead of print, accepted 8 val grafting: an experimental study in dogs; Clinical Oral Implant Research January 2014, 2014 26, 176–182, 2015, doi: 10.1111/clr.12280 -Maiorana C, Farronato D, Pieroni S, Cicciù M, Andreoni D, Santoro F; -Micarelli C, Canullo L, Giuliano I.; Implant/abutment connection deforma- A four-year survival rate multicenter prospective clinical study on 377 tion after prosthetics procedures - an in vitro study ; International Journal implants - correlations between implant insertion torque, diameter and of Prosthodontics, 1-9,2014, Early view in ahead of print, accepted July bone quality; Journal of Oral Implantology, 2014, Early view in ahead of 21st, 2015 doi to be attributed print, accepted 11 February 2014 -Peñarrocha-Oltra D, Covani U, Peñarrocha M, Peñarrocha-Diago M.; -Canullo L, Peñarrocha-Oltra D, Soldini C, Mazzocco F, Peñarrocha Immediate versus conventional loading with fixed full-arch prostheses in M, Covani U; Microbiological assessment of the implant-abutment mandibles with failing dentition: a prospective controlled study; Interna- interface in different connections: cross-sectional study after 5 years tional Journal of Oral and Maxillofacial Implants 30, 2015:427–434; doi: of functional loading; Clinical Oral Implant Research, 00, 2014: 1-9, Early 10.11607/jomi.3534 view in ahead of print, accepted 22 February 2014, doi 10.1111/clr.12383 -Prati C, Zamparini F, Ciulla A, Buonavoglia A, Gatto MR, Piattelli A, -Mainetti T, Lang N, Bengazi F, Sbricoli L, Soto Cantero L, Botticelli D.; Gandolfi MG; Evaluation of marginal bone level of Premium implants; XXIII Immediate loading of implants installed in a healed alveolar bony ridge Congress SIO, Milano 6-7 febbraio Poster; 2015 or immediately after tooth extraction: an experimental study in dogs; -Gandolfi MG, Siboni F, Piattelli A, Prati C; Nano-topography, microche- Clinical Oral Implant Research, 00, 2014: 1-8, Early view in ahead of print, mical properties and calcium phosphate nucleation of Premium implants; accepted 5 March 2014, doi 10.1111/clr.12389 30th Annual Congress, American Academy of Osseointegration, San -Engelhardt S, Papacosta S, Rathe F, Ozen J, Jansen J.A., Junker R.; Francisco, 12-14 March Poster , 2015 Id 2088727 Annual failure rates and marginal bone-level changes of immediate com- -Guazzotti PP; Carico immediato di impianti post estrattivi: presentazione pared to conventional loading of dental implants. A systematic review di un caso clinico full-arch; Doctor Os, XXVI, 01, gennaio 24-29 ; 2015 of the literature and meta-analysis; Clinical Oral Implant Research, 00, -Penarrocha-Oltra D, Rossetti PHO, Covani U, Galluccio F, Canullo L; 2014: 1-17, Early view in ahead of print, accepted 9 February 2014, doi Microbial leakage at the implant/abutment connection due to implant 10.1111/clr.12363 insertion maneuvers: cross-sectional study 5 years post loading in -Bruschi GB, Crespi R, Capparè P, Grande N, Bruschi E, Gherlone E; healthy patients.; Journal of Oral Implantology, accepted for publication Radiographic evaluation of crestal bone levels of delayed implants at5 January 2015 medium term follow up; International Journal of Oral & Maxillofacial -Agustín-Panadero R., Serra-Pastor B., Chust-López C., Fons-Font Implants, 29;2014: 441-447 doi 10,11607/jomi.3254 A., Ferreiroa A. ; Immediate placement of single implant simultaneou- -Sbordone C, Toti P, Martuscelli R, Guidetti F, Sbordone L, Ramaglia L; A sly with immediate loading in a fresh socket associated to periapical 5-year implant follow-up in maxillary and mandibular horizontal osseous infection: A clinical case report; Journal of Clinical and Experimental onlay grafts and native bone; Journal of Oral Implantology, Early view in Dentistry. ;7(1), 2015:175-9 ahead of print, accepted 4 March 2014; 2014 -Canullo L., Peñarrocha-Oltra D., Covani U., Botticelli D., Serino G., -Canullo L, Micarelli C, Bettazzoni L, Magnelli A, Baldissara P; Shear Peñarrocha M.; Clinical and microbiological findings in patients with bond strength of veneering porcelain to zirconia after argon plasma peri-implantitis: a cross-sectional study; Clinical Oral Implant Research, treatment; International Journal of Prosthodontics, Mar-Apr, 27(2), 2014: 00, 1-7,2015 ; doi: 10.1111/clr.12557 137-9, 2014 doi: 10.11607/ijp.3722 -Mainetti T, Lang NP, Bengazi F, Favero V, Soto Cantero L, Botticelli D; -Canullo L, Micarelli C, Bettazzoni L, Koçi B, Baldissara P; Zirconia-Com- Sequential healing at implants installed immediately into extraction posite bonding after plasma of argon treatment; International Journal of sockets. An experimental study in dogs; Clinical Oral Implant Research, Prosthodontics, 27:267-269, 2014, doi: 10.11607/ijp.3686 00, 1-9, 2014, doi: 10.1111/clr.12533 -Peñarrocha-Oltra D, Peñarrocha-Diago M, Canullo L, Covani U, Peñarr- -Beolchini M, Lang NP, Gomez Moreno G, Iezzi G, Botticelli D, Calvo Gui- ocha Miguel; Patient-reported outcomes of immediate versus conventio- rado JL; Bone healing at implants with different surface configuration: nal loading with fixed full-arch prostheses in the maxilla: a non-rando- an experimental study in dogs; Clinical Oral Implant Research 00, 1-7, mized controlled prospective study; The International Journal of Oral & 2015, doi: 10.111/clr.12562 Maxillofacial Implants, 29 (3), 690-698; 2014 -Borgia V, Alfonsi F, Toti P, Tonelli P, Covani U, Barone A; Immediate resto- -Covani U, Canullo L, Toti P, Alfonsi F, Barone A; Tissue stability of ration of post-extraction implants. A 7 years prospective single cohort implants placed in fresh extraction sockets - a 5 year prospective single study.; 30th Annual Congress, American Academy of Osseointegration, cohort study; Journal of Periodontology, 85: 323-332, 2014, doi 10.1902/ San Francisco, 12-14 March Poster ; 2015 jop2014.140175 -Kern JS, Kern T, Wolfart S, Heussen N;A systematic review and meta-a- -De Santis E, Lang NP, Favero G, Beolchini M, Morelli F, Botticelli D.; He- nalysis of removable and fixed implant-supported prostheses in edentu- aling at mandibular block-grafted sites. An experimental study in dogs; lous jaws: post-loading implant loss; Clinical Oral Implant Research, 00, Clinical Oral Implant Research, 00, 2014: 1-7, Early view in ahead of print, 1-22, 2015, doi: 10.1111/clr.12531 accepted 17 May 2014, doi 10.1111/clr.12434 -Crespi R, Bruschi GB, Gastaldi G, Capparè P, Gherlone EF ; Immediate -Crespi R, Brusch GB, Capparè P, Gherlone E.; The utility of the electric loaded implants in split-crest procedure; Clin Implant Dent Relat Res., mallet; The Journal of Craniofacial Surgery, 25 May (3), 793-795, 201, Mar 17. 2015 doi: 10.1111/cid.12316 2014, doi 10,1097/SCS.0000000000000523;2014 -Martín Anciburo Miguel Ángel; Rehabilitación unitaria implantosopor- -Covani U, Marconcini S, Ferrini F, Gelpi F, Finotti M, Barone A.; tada utilizando la técnica B.O.P.T.; Numeri Uno 04, 2015: 11-14 Post-traumatic use of dental implants immediately after tooth ex- -Requena Gómez E., Cervantes Haro MN, Aragoneses Lamas JM ; ¿Es traction - clinical study; The Journal of Craniofacial Surgery, 25 May (3), la cirugía guiada junto a la carga inmediata una técnica predecible? A 796-798, 2014, doi 10,1097/SCS.0000000000000522 propósito de un caso clínico; Numeri Uno 04, 2015: 16-19 -Calesini G, Zarone F, Sorrentino R, Micarelli C, Fabianelli A, Papacchini -Canullo L, Peñarrocha-Oltra D, Marchionni S, Bagán L, Peñarr- F, Gherlone E.; Effect of 2 impression techniques on the dimensional ocha-Diago MA, Micarelli C.; Soft tissue cell adhesion to titanium accuracy of working implant prosthesis models - an in vitro study; The abutments after different cleaning procedures: Preliminary results of a Journal of Craniofacial Surgery, 25 May (3), 822-827, 2014, doi 10,1097/ randomized clinical trial.; Medicina Oral y Patologia Oral Cirurgia Bucal, SCS.0000000000000715 published on line 2013 Oct 13, 2014 Mar 1;19(2): el 77-83, doi: 10.4317/ -Quaranta A, Andreana S, Pompa G, Procaccini M; Active implant peri-a- medoral.19329 pical lesion - a case report treated via guided bone regeneration with a -Pellicer-Chover H, Peñarrocha-Oltra D, Bagán L, Fichy-Fernandez AJ, 5-year clinical and radiographic follow-up; Journal of Oral Implantology, Canullo L, Peñarrocha-Diago M; Single blind randomized clinical trial to 40 (3), 313-319, 2014, doi: 10,1563/AAI.JOI.D.11.00214 evaluate clinical and radiological outcomes after one year of immediate -J. Viña-Almunia ; Microbial colonization of the implant connection with versus delayed implant placement supporting full-arch prosthesis; cemented versus screw-retained suprastructures; Oral presentation Medicina Oral y Patologia Oral Cirurgia Bucal, 1; 19(3), 2014: 295-301, doi: ,Clinical research - Prosthetically oriented 10.4317/medoral.19536 -EAO Congress, Rome 25-27 September 2014, Clinical Oral Implant -Crespi R, Capparè P, Polizzi E, Gherlone E; Fresh-socket implants of Research, 25 (suppl. 10), 93, 2014 different collar length: Clinical evaluation in the aesthetic zone; Clinical -Cocchetto R.; Improved cementation technique for implant restorations Implant Dentistry and Related research, 00, 2014 : 1-8, early view in ahe- to avoid periimplant cement remnants: clinical and microscopical eva- ad of print, first published on line 7 Feb 2014 doi 10,1111/cid.12202 luation with two different abutment design; Oral presentation, Clinical -Negri B, López Marí M, Maté Sánchez de Val JE, Iezzi G, Bravo González research - Prosthetically oriented LA, Calvo Guirado JL; Biological width formation to immediate implants -EAO Congress, Rome 25-27 September 2014, Clinical Oral Implant 59 BIBLIOGRAFIA RELATIVA AGLI IMPIANTI SWEDEN & MARTINA DAL 2013

Research, 25 (suppl. 10), 96; 2014 -Pradíes Ramiro G., Abad Coronel C., García Martínez I., Ferreiroa Na- -Augustín-Panadero R, Serra-Pastor B, Roig-Vanaclocha A, Román-Rod- varro A.; Impresiones fiables: dos propuestas para un mismo objetivo; riguez JL, Fons-Font A; Mechanical behavior of provisional implant Numeri Uno, 01, 2014, 6-9 prosthetic abutments; Medicina Oral Patologia Oral y Cirurgia Bucal, -Machín Muñiz A.; Regeneración ósea y gingival en implantes inmediatos 1-9, 2014, Early view in ahead of print, accepted July 2014, doi 10,4317/ post-extracción; Numeri Uno 01 , 2014: 20-21 medoral.19958, -Loi I.; Riabilitazione implanto-protesica di elemento incisivo frontale -Micarelli C, Canullo L, Giuliano I.; Implant/abutment connection defor- con impianto Prama; Numeri Uno 20, 2014: 12-13 mation after prosthetics procedures - an in vitro study ; International -Loi I.; Riabilitazione implanto-protesica di ponte distale con impianti Journal of Prosthodontics, 1-9,2014, Early view in ahead of print, accep- Prama; Numeri Uno 20, 2014: 14-15 ted July 21st, 2015 doi to be attributed -Gorni F.; Riabilitazione di elemento singolo in zona estetica con impian- -Kinaia BM, Shah M, Neely AL, Goodies HE; Crestal bone level changes to Prama RF; Numeri Uno 20, 2014: 16-17 around immediately placed implants - A systematic review and meta-a- -Vedove F.; Riabilitazione di elemento singolo in zona estetica con im- nalyses with at least 12 months follow up after functional loading; Jour- pianto Prama; Numeri Uno 20, 2014: 18-19 nal of Periodontology, 2014, early view in ahead of print, doi: 10,1902/ -Andreoni D.; Riabilitazione di elemento singolo in posizione 4.6 con jop2014,130722;2014 impianto Prama; Numeri Uno 20, 2014: 20-21 -Cicciù M, Bramanti E, Matacena G, Guglielmino E, Risistano G.; FEM -Sandri L.P.; Utilizzo clinico dei nuovi impianti Prama: inserimento e evaluation of cemented-retained versus screw-retained dental im- riabilitazione con un singolo impianto; Numeri Uno 20, 2014: 22-24 plant single-tooth crown prosthesis; International Journal of Clini- -Csonka M.; Trattamento implantologico delle creste sottili: Split Crest o cal and Experimental Medicine 7(4) , 2014: 817-825; doi: 1940-5901. GBR?; Numeri Uno 19, 2014: 12-14 ijcem.1402025 -Vischia F., Roncoroni F.; Ortodonzia protesica mediante tecnica B.O.P.T.; -Crespi R, Capparè P, Polizzi EM, Gherlone EF.; Tissue remodeling after Numeri Uno 19, 2014: 19-21 bone expansion in grafted and ungrafted sockets; The International -Schirripa G., Schirripa F.; Carico immediato; Numeri Uno 19, 2014: 22-24 Journal of Oral and Maxillofacial Implants, 29, 2014: 699-704, , doi: -Baldi D., Colombo J., Pera P., Hauschild U.; Una tecnica minimamen- 10,11607/jomi.3535 te invasiva: implantologia con utilizzo di impianti a diametro ridotto e -Bruschi GB, Crespi R, Capparè P, Gherlone E.; Clinical Study of flap tecniche CAD CAM per una provvisorizzazione a lungo termine; Numeri design to increase the keratinized gingiva around implants - a 4 year fol- Uno 18, 2014: 6-9 low-up; Journal of Oral Implantology, 40(4) , 2014: 459-464, doi: 10,1563/ -Gaspari L.; Implantoprotesi conometrica elettrosaldata chairside a aaid-joi-d-11-00236 carico immediato - caso clinico; Numeri Uno, 18, 2014:12-14 -Romanos GR, Javed F.; Platform switching minimises crestal bone loss -Loi I.; Tecnica B.O.P.T. su denti e impianti per la riabilitazione di un’arca- around dental implants - truth or myth?;Journal of Oral Rehabilitation, ta completa; Numeri Uno 18 , 2014:21-22 2014, early view in ahead of printing, accepted for publication 30 Aril -Morandini E. ; La precisione nel Cr.Co. laser sinterizzato rivestito in 2014, doi 10,1111/joor.12189 ceramica; NumeriUno 17, 2013: 9-11 - NumeriUno 18, 2014: 16-19 -Gaspari L.; Tecnica conometrica con provvisorio elettrosaldato per -Loi I.; Técnica B.O.P.T. sobre dientes naturales; Numeri Uno 02, 2014: 8-9 carico immediato; Italian Dental Journal, agosto, 29; 2014 -Loi I.;Técnica B.O.P.T. sobre dientes e implantes para la rehabilitación de -Lumetti S, Galli C, Smerieri A, Macaluso G, Manfredi E, Ghiacci G, los dos arcos completos;Numeri Uno 02, 2014 : 14 Di Blasio A, Megri M.; The effect of age, gender and insertion site on -Canullo L, Cassinelli C, Goetz W, Tarnow D; Il plasma di argon accelera marginal bone loss around endosseous implants: results for a 3 year l’adesione dei fibroblasti murini nelle fasi precoci della colonizzazione trial; Poster, EAO Congress, Rome 25-27 September 2014, Clinical Oral di dischetti in titanio; International Journal of Oral and Maxillofacial Implant Research, 25 (suppl. 10), 440; 2014 Implants 2013; 28: 957-962. DOI: 10,11607/jomi.2664 -Lumetti S, Di Blasio A, Manfredi E,Ghiacci G, Toffoli A, Bonanini M, -Bengazi F, Botticelli D, Favero V, Perini A, Urbizo Velez J, Lang NP ; Macaluso G, Galli C.; Implant surface microtopography affects the patter Influence of presence or absence of keratinized mucosa on the alveolar of cell growth, cell-to-cell contacts and the expression of Connexin bony crest level as it relates to different buccal margin bone thicknes- 43;Poster, EAO Congress, Rome 25-27 September 2014, Clinical Oral ses. An experimental study in dogs; Clinical Oral Implant Research, 00, Implant Research, 25 (suppl. 10), 222; 2014 2013, 1-7, Accepted 26 June 2013, first published on line on 29/07/2013, -Caneva M, Lang NP, Calvo Guirado JL, Spriano AM, Iezzi G, Botticelli D.; DOI 10,1111/clr.12233 Bone healing at bicortically installed implants with different surface -Peñarrocha-Oltra D, Covani U, Aparicio A, Ata-Ali J, Peñarrocha-Diago configurations. An experimental study in rabbits; Clinical Oral Implant Miguel, Peñarrocha-Diago María; Immediate versus conventional loading Research, 00, 2014: 1-7, Early view in ahead of printing, accepted 29 July for the maxilla with implants placed into fresh and healed extraction 2014, doi:10.1111/clr.12475 sites to support a full-arch fixed prosthesis: nonrandomized controlled -D’Ercole S, Tripodi D, Marzo G, Bernardi S, Continenza MA, Piattelli A, clinical study; International Journal of Oral and Maxillofacial Implants Iaculli F, Mummolo S.; Microleakage of bacteria in different implant-a- 2013; 28: 1116-1124 DOI: 10.11607/jomi.3119 butment assemblies: an in vitro study; Journal of Applied Biomaterial -Covani U, Ricci M, Tonelli P, Barone A; An evaluation of new designs and Functional Materials, 2014, accepted June 12, 2014, doi: 105301/ in implant-abutment connections: a finite element method asses- jabfm.5000214 sment; Implant Dentistry, 2013, Jun22(3): 263-267, DOI 10.1097/lD. -Peñarrocha-Oltra D, Peñarrocha-Diago M, Aloy-Prosper A, Covani U, 0b013e318292625f Peñarrocha M.; Immediate versus conventional loading of complete-arch -Crespi R, Capparè P, Gherlone EF, ; Electrical mallet in implants placed implant-supported prostheses in mandibles with failing dentition: a in fresh extraction sockets with simultaneous osteotome sinus floor patient centered controlled prospective study; Journal of oral and Maxil- elevation; International Journal of Oral and Maxillofacial Implants, 2013; lofacial Implants, submitted; 2014 28(3): 869-874, doi: 10.11607/jomi,2679 -Bowen Antolín A, Ariño B, Arlandi Garrido M.; Regeneración ósea periim- -Panadero RA, Fons Font A, Granell Ruíz M, Román Rodríguez JL, Solá plantaria con fosfato de calcio bifásico y ácido poliláctico;Gaceta Dental, Ruíz MF, Rubio Cebriá J; Sobredentadura implantosoportada de inser- 260(7), 2014: 174-186; ción horizontal; Gaceta Dental, 249: 100-112, 2013 -Morelli F, Lang NP, Bengazi F, Baffone D, Vila Morales CD, Botticelli D.; -Beolchini M, Lang NL, Viganò P, Bengazi F, Triana BG, Botticelli D; The Influence of bone marrow on osseointegration in long bones: an expe- edentolous ridge expansion (ERE) technique - an experimental sudy in rimental study in sheep; Clinical Oral Implant Research, 00, 1-7, 2014, dogs; Clinical Oral Implant research, 2013: 1-7, published on line early Early view in ahead of printing, accepted 29 August 2014, doi:10.1111/ view in ahead of print in September 2013, doi: 10.1111/clr.12262 clr.12487 -Bressan E., Lang NP, Corazza B, Rizzi S, Almagro Urrutia Z, Botticelli -Marchetti E, Ratta S, Mummolo S, Tecco S, Pecci R, Bedini R, Marzo G.; D; The Platform Switching concept revisited. An experimental study in Evaluation of an endosseus oral implant system according to UNI EN ISO dogs; Clinical Oral Implant research, 2013: 1-5, published on line early 14801 Fatigue Test Protocol; Implant Dentistry, 2014, Early View in ahead view in ahead of print in September 2013, doi: 10.1111/clr.12263 of print, doi: 10.1097/id.151 -Crespi R, Capparè P, Gherlone EF, ; Electrical mallet provides essential -Negri M, Galli C, Smerieri A, Macaluso GM, Manfredi E, Ghiacci G, Toffoli advantages in split-crest and immediate implant placement ;Oral and A, Bonanini M, Lumetti S; The effect of age, gender and insertion site on Maxillofacial Surgery, 2013, (18): published on line early view in ahead of marginal bone loss around endosseous implants: results from a 3-year print in January 2013, doi: 10.1007/s10006-013-0389-2 trial with Premium Implant System; BioMed research International, Volu- -Canullo L, Peñarrocha-Oltra D, Marchionni S, Bagán L, Peñarr- me 2014, Article ID 369051, 7 pages, doi.org/10.1155/2014/369051 ocha-Diago MA, Micarelli C.; Soft tissue cell adhesion to titanium -Esposito M, Ardebili Y, Worthington HV; Interventions for replacing abutments after different cleaning procedures: Preliminary results of a missing teeth: different types of dental implants (Review);The Cochrane randomized clinical trial.; Medicina Oral y Patologia Oral Cirurgia Bucal, Collaboration, John Wiley and Sons, Ltd; 2014 published on line 2013 Oct 13, 2014 Mar 1;19(2): el 77-83, doi: 10.4317/ -Mainetti T, Lang NP, Bengazi F, Favero V, Soto Cantero L, Botticelli D; medoral.19329 Sequential healing at implants installed immediately into extraction -Canullo L, Peñarrocha D, Peñarrocha M, Rocío A-G, Peñarrocha-Diago sockets. An experimental study in dogs; Clinical Oral Implant Research, M.; Piezoelectric vs. conventional drilling in implant site preparation: 00, 1-9, 2014, doi: 10.1111/clr.12533 pilot controlled randomized clinical trial with crossover design.; Clinical -Crespi R, Capparè P, Gastaldi G, Gherlone EF; Immediate Occlusal loa- Oral Implant Research 00, 2013, 1–8, published on line early view in ding of full-arch rehabilitations: screw-retained versus cement-retained ahead of print in October 2013, doi: 10.1111/clr.12278 prosthesis. An 8 year clinical evaluation; International Journal of Oral & -Micarelli C, Canullo L, Grusovin MG, Peñarrocha Oltra D, ;Cell adhesion 60 Maxillofacial Implants 29, 2014:1406-1411; doi: 10.11607/jomi.3746 to titanium abutments after different cleaning procedures; Clinical Oral BIBLIOGRAFIA RELATIVA AGLI IMPIANTI SWEDEN & MARTINA DAL 2013

Implant Research, 24(Suppl.9), 2013 : 79-102 -Fadda M.; Caso clinico con M.F. Extrusion; Numeri Uno, 17, 2013:26 -Canullo L, Peñarrocha D, Covani U, Micarelli C, Massidda O, ; Hard -Cardarelli F.; Effetti dentofacciali della terapia ortodontica in dentizio- Tissue response to plasma of argon cleaning treatment on titanium ne mista per la correzione delle II Classi; Numeri Uno 17, 2013: 28-31 abutments - 2 year follow-up RCT; Clinical Oral Implant Research, -Calesini G., Scipioni A.; Approccio rigenerativo sistematico finalizzato 24(Suppl.9), 27-47 , 2013 all’integrazione morfo-funzionale in implantoprotesi; Numeri Uno 16, -De Risi V, Clementini M, Vittorini G, Mannocci A, De Sanctis M; Alveolar 2013: 6-9 ridge preservation techniques: a systematic review and meta-analysis of -Ponzi A.; Echo Plan: accuracy dell’implantologia guidata; Numeri Uno histological and histomorphometrical data; Clinical Oral Implant Resear- 16, 2013: 12-13 ch, 00, 2013: 000-000, Early view in ahead of print, accepted September -Canullo L., Cicchese P., Marinotti F.; Riabilitazione implanto-supportata 2013, doi 10.1111/clr.12288 di entrambi i mascellari edentuli con carico immediato; Numeri Uno 16, -Canullo L, Peñarrocha D, Clementini M, Iannello G, Micarelli C; Impact 2013: 14-15 of plasma of argon cleaning treatment on implant abutments in patients -Sisti A., Mottola M.P., Mottola P.; Riabilitazione bilaterale con chirurgia with a history of periodontal disease and thin biotype - radiographic guidata; Numeri Uno 16, 2013: 16-18 results at 24 months follow-up of a RCT; Clinical Oral Implant Research, -Csonka M.; Split crest di una cresta molto sottile con il Magnetic Mallet; 00, 2013: 000-000, Early view in ahead of print, accepted 18 September Numeri Uno 16, 2013: 22-23 2013, doi 10.1111/clr.12290 -Guidi R, Viscioni A, Dattola F, Carinci F;Dental implants inserted in -Canullo L, Peñarrocha D, Micarelli C, Massidda O, Bazzoli M; Hard native bone: cases series analyses; Dental Research Journal, 12(9), Issue tissue response to argon plasma cleaning / sterilization of customised 8 (Suppl Issue 2), 175-180; 2012 titanium abutments versus 5-second steam cleaning: results of a 2-year -Canullo L, Cicchese P, Marinotti F, ; Valutazione di una procedura clinica post-loading follow-up from an explanatory randomized controlled trial e tecnica per la riabilitazione dei mascellari edentuli; Il Dentista Moder- in periodontally healthy patients; European Journal of Oral Implantology. no, Marzo: 86-102, 2012 Autumn ; 6(3) ,2013:251-60 -Canullo L, Cicchese P, Marinotti F, Sisti A; Strategia protesica mini- -Petrillo N.; Carico immediato full arch mascellare e mandibolare: un mamente invasiva negli impianti post-estrattivi: posizionamento e nuovo approccio chirurgico e protesico; Il Dentista Moderno, 2013 No- avvitamento immediato del moncone definitivo per protesi su impianti vembre 2013: 82-96 secondo il concetto del platform switching; Il Dentista Moderno, Dicem- -Baffone G, Lang NP, Pantani F, Favero G, Ferri M, Botticelli D; Hard and bre: 46-54, 2011 soft tissue changes around implants installed in regular-sized and re- -Segura Andrés G., Martìnez Lage J. F., Ferreiroa A., Faus Lòpez J., duced alveolar bony ridges. An experimental study in dogs; Clinical Oral Agustìn Panadero R.; Rehabilitación protésica en un maxilar atrófico a Implant Research, 00, Early view in ahead of print, accepted 28 October consecuencia de un trauma facial; Gaceta Dental, 2013; 244:112-118 2013: 1-6, doi 10.1111/clr.12306 -Canullo L., Micarelli C., Clementini M.; Hard tissue response to argon -Beolchini M, Lang NL,Ricci E, Bengazi F, Garcia Triana B, Botticelli D; plasma cleaning treatment on titanium abutments: 2-year follow-up Influence on alveolar resorption of the buccal bony plate width in the RCT; European Journal of Oral Implantology, 6 (Suppl. Spring), 2013: edentolous ridge expansion (E.R.E.) - an experimental study in the dog; S21-S22 Clinical Oral Implant Research, 00, 2013: 1-6, Early view in ahead of print, -Rossi F., Lang N. P., De Santis E., Morelli F., Favero G., Botticelli D.; accepted 28 October 2013doi 10.1111/clr.12308 Bone-healing pattern at the surface of titanium implants: an experi- -Strietzel FP, Neumann K, Hertel M ; Impact of platform switching on mental study in the dog; Clinical Oral Implant Research, Early View, First marginal peri-implant bone-level changes. A systematic review and Published online on 2013, January 4th; DOI: 10.1902/jop.2010.100428 meta-analysis; Clinical Oral Implant Research, 00, 2014: 1-16, Early view -Clementini M., Canullo L., Micarelli C.; Fibroblast growth on titanium in ahead of print, accepted 11 December 2013, doi 10.1111/clr.123339 disks treated by argon plasma: an in vitro triple-blinded study; European -Morandini E. ; La precisione nel Cr.Co. laser sinterizzato rivestito in Journal of Oral Implantology, 6 (Suppl. Spring), 2013: S29-S30 ceramica; NumeriUno 17, 2013: 9-11 - NumeriUno 18, 2014: 16-19 -Canullo L., Micarelli C., Iannello G.; Microscopical and chemical -Sandri L.P. ; Preparazione protesica mediante tecnica B.O.P.T.: caso surface characterization of the gingival portion and connection of an clinico; Numeri Uno 17, 2013 :6-8 internal hexagon abutment before and after different technical stages -Corrente G., Abundo R., Greppi M., Perelli M., Villa A.; Posizionamento of preparation; Clinical Oral Implant Research, 2013, 24: 606-611; DOI: implantare e ricostruzione dei tessuti duri e molli: un protocollo semplifi- 10.1111/j.1600-0501.2012.02499.x cato; Numeri Uno 17, 2013:14-17 -Canullo L., Heinemann F., Gedrange T., Biffar R., Kunert-Keil C.; Histo- -Avellino W., De Maria A., Milan U., Tamagnone L., Delle Rose D.; Direct logical evaluation at different times after augmentation of extraction Prosthetic Framework (D.P.F.); Numeri Uno, 17, 2013: 18-20 sites grafted with a magnesium-enriched hydro xypatite: double-blinded -Figliuzzi M. M., De Fazio R., Tiano R., Scordamaglia F., Fortunato L.; randomized controlled trial; Clinical Oral Implant Research, Early View, Riabilitazione con impianto post-estrattivo immediato in zona estetica: First Published online on 2013,January 4th; DOI: 10,1111/clr.12035 Case Report; Numeri Uno 17, 2013:21-22

61 NOTE

62 are correct at the time of publication. Please contact Sweden & Martina S.p.A. for information on any subsequent updates. subsequent any on information for S.p.A. &Martina Sweden contact Please publication. of time the at correct are manual this of contents The the consult please side-effects, potential and website. precautions S.p.A. warnings, &Martina Sweden contraindications, indications, including S.p.A. illustrated, &Martina products Sweden the of on consent information written prior further the For without manual this in illustrated products the patients. to sale disclose or direct for duplicate sell, to intended not are and prohibited is It laboratories, technology dental and clinics dental for intended are products These manual this in present names brand All markets. all on available be not may products Some countries. other and USA the in applicable cGMPs the with accordance in devices medical manufacture facilities production &Martina Sweden 2007/47/EC. Directive European and 93/42/EEC accordance in IIB) Class and Directive IIA 0476 (Class Devices Mark CE and I) Medical (Class Mark CE European as the with registered are and standards, S.p.A. 13485 ISO and &Martina 9001 ISO the Sweden by with compliant are manufactured devices illustrated medical are articles The manual this in illustrated instruments surgical and components prosthetic implants, The www.sweden-martina.com [email protected] +39.049.9124290Fax Tel. +39.049.9124300 (PD), Italy Carrare Due 35020 10 Veneto, Via S.p.A. &Martina Sweden are the property of Sweden & Martina, except for those products for which other indications are given. given. are indications other which for products those for except &Martina, Sweden of property the are [email protected] Tel. 900993963 Tel. +34.96.3525895 Spain 46015-Valencia, 8pl 58, Valencianas Cortes Avda 801 Oficina Center, Sorolla Sweden & Mediterranea S.L. Martina [email protected] Hotline 08001827699 Germany D -81379 München 46 Rupert-Mayer-Straße GmbH Deutschland &Martina Sweden [email protected] 844-862-7846 Toll free 844-8MARTINA 17301 US PA, Abbottstown, St. 301 Pleasant Management c/o DCI Inc. &Martina Sweden rev. 07-16 rev.

MC-IMP-CSRDAT-E