Rajiv Gandhi University of Health Sciences s161
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA , BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
TOPIC
Comparison of the efficacy of a combination of platelet rich fibrin and biograft- HT® with that of platelet rich fibrin alone in healing of mandibular third molar sockets - A Prospective clinical study
DR. MD. H. SHAKEEB ULLAH.
POST GRADUATE STUDENT
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
K.V.G. DENTAL COLLEGE AND HOSPITAL
SULLIA, D.K. – 574327
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESBANGALORE – KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1) NAME OF THE CANDIDATE
AND ADDRESS / DR. MD.H.SHAKEEB ULLAH
POST GRADUATE STUDENT,
DEPT. OF ORAL AND MAXILLOFACIAL SURGERY,
K.V.G. DENTAL COLLEGE AND HOSPITAL, KURUNJIBAG,
SULLIA- 574327.
2) NAME OF THE INSTITUTION / K.V.G DENTAL COLLEGE AND HOSPITAL, KURUNJIBAG,
SULLIA- 574327
3) COURSE OF STUDY AND
SUBJECT / MASTER OF DENTAL SURGERY
(ORAL AND MAXILLOFACIAL SURGERY )
4) DATE OF ADMISSION TO
COURSE. / 29-07-2013
5) TITLE OF THE TOPIC / Comparison of the efficacy of a combination of platelet rich fibrin and biograft- HT® with that of platelet rich fibrin alone in healing of mandibular third molar sockets - A Prospective clinical study
6.) BRIEF RESUME OF THE INTENDED WORK
6.1) Need for the study:
Reconstruction of bony defects represents a challenging problem for the surgical community. Many defects in facial skeleton may significantly impair proper prosthetic and functional rehabilitation of the stomatognathic system. 1
Platelet Rich Growth Factors (PRGF) are very successful in stimulating bone regeneration and promote healing after the surgical removal of third molar tooth 2
Platelet rich fibrin (PRF) is a newer material which is referred to as a second-generation platelet concentrate. It contains all constituents of a blood sample favorable for healing and immunity on a single fibrin membrane. It is successfully used in healing of the wound2.
Platelet rich fibrin (PRF) is both healing and interpositional biomaterial. As a healing material, it accelerates wound closure and mucosal healing due to fibrin bandage and growth factor release. As interpositional material, it avoids the early invagination for undesired cells, thereby behaves as a competitive barrier between desired and undesired cells2.
Alloplastic bone graft materials are synthetic, inorganic, biocompatible, and bioactive bone substitutes that are believed to promote healing of bone defects through osteoconduction.
Several calcium phosphate biomaterials have been tested since the mid-1970. They have excellent tissue compatibility and do not elicit any inflammation or foreign body response. Two types of calcium phosphate ceramics have been used, hydroxyapatite (HA) and tricalcium –phosphate2.
Biograft- HT® is a biphasic calcium phosphate consisting of hydroxyapatite (HA) and beta-tricalcium phosphate in the weight % ratio of approximately 60:40 that is biocompatible, non-toxic, resorbable, non-inflammatory, and bioactive. It causes no immunological, foreign-body, or irritating response, and has excellent osteoconductive ability. Hydroxyapatite has a stoichiometry similar to natural bone and provides an osteoconductive scaffold in the bone regenerative process6.
Socket healing is a highly co-ordinated sequence of biochemical, physiologic, cellular and molecular responses involving numerous cell types, growth factors, hormones, cytokines, and other proteins, which is directed towards restoring tissue integrity and functional capacity after injury. Third molar socket provides a very good study model to assess the role of various biomaterials in healing.
There are several studies1,2,4,5 to assess the role of platelet rich fibrin (PRF) in healing sockets as well as bony defects, similarly there are studies to prove the role of alloplastic materials such as hydroxyapatite (HA) as well as biograft- HT® in healing of bony defects in the oral cavity6.
However there is no single study that compares the efficacy of platelet rich fibrin (PRF) with that of a combination of platelet rich fibrin (PRF) with biograft- HT® in healing sockets.
We believe there is a need to continuously look for newer biomaterials or combinations of existing alloplastic materials with autografts to find out any additional advantages and superiority in terms of healing. This study is an attempt in that direction.
Hence we feel there is a need for a study comparing the efficacy of a combination of platelet rich fibrin and biograft- HT® with that of Platelet rich fibrin alone in mandibular third molar sockets.
6.2) Review of literature:
Choukroun et al1 evaluated the potential of PRF in combination with Freeze-dried bone allograft (FDBA) to enhance bone regeneration in sinus floor elevation. This study was a case of 9 sinus elevations with FDBA with or without PRF. Bone fragments were analyzed. Preliminary analysis highlight mineralized trabecular bone rich in osteocytes with important osteoid borders in contact with dense cellular osteoblast fronts. Hence they concluded PRF membranes have potential to treat sinus membrane perforation
Sunitha and Munirathnam2, elaborated the method of preparation of the platelet rich plasma (PRP) and platelet rich fibrin(PRF). PRP is a platelet concentrate and has been used widely to accelerate soft- tissue and hard-tissue healing. Platelet rich fibrin (PRF) was first discovered by Choukroun et al. in France. In their review article they have described the evolution of this novel platelet concentrate which is referred to as PRF.
Olufemi et al 3, conducted A prospective randomized comparative clinical study was undertaken
over a 2-year period. Patients requiring surgical extraction of a single impacted third molar and who fell within the inclusion criteria and indicated willingness to return for recall visits were recruited. The predictor variable was application of PRP gel to the socket of the third molar in the test group, whereas the control group had no PRP. The outcome variables were pain, swelling, and maximum mouth opening, which were measured using a 10-point visual analog scale, tape, and millimeter caliper, respectively. Socket healing was assessed radiographically by allocating scores for lamina dura, overall density, and trabecular pattern. Sixty patients aged 19 to 35 years (mean: 24.7 _ 3.6 years) were divided into both test and control groups of 30 patients each. The mean postoperative pain score (visual analog scale) was lower for the PRP group at all time points and this was statistically significant (P _ .05). Although the figures for swelling and interincisal mouth opening were lower in the test group, this difference was not statistically significant. Similarly, the scores for lamina dura, trabecular pattern, and bone density were better among patients in the PRP group. This difference was also not statistically
significant.
Shepherd et al4 conducted a prospective Randomised Controlled Trial where fibrin sealant (human) is used in 10 consecutive patients undergoing lateral osteotomy in Rhinoplasty. Fibrin sealant was used on either the right or the left side with the contralateral side acting as the control. The observers evaluated all photographs and completed a grading scale to define bruising and swelling on each side. Then after seeing the results they declared that Fibrin sealant applied to a lateral osteotomy site significantly reduced bruising and swelling.
Michael et al5 did a prospective study on 110 patients where 138 implants were placed using osteotome-mediated sinus floor elevation (OMSFE) with PRF. The mean increase in the height of implant sites by OMSFE/PRF was 3.4mm. 138 implants that had been placed, 97 have been restored and in function for an average loading time of 5.2 months. Then in the end they concluded that OMSFE/PRF technique presented for localized sinus floor elevation and implant placement demonstrates a high degree of safety and success at sites with 5mm to 8mm residual sub-antral bone height.
Chandrashekhar and Saxena6, diagnosed twenty patients with generalized chronic periodontitis having two or more vertical defects were selected for this study.Radiographic evaluation included the depth of the bone defect and the percentage of bone defect fill and was carried out for both the groups at baseline, three months and six months.After recording clinical parameters and administering phase-1 therapy, the sites were randomly treated either with biograft- HT®or open flap debridement only. After the study they concluded that biograft- HT®improves healing outcomes, leads to a reduction of probing depth, a resolution of osseous defects and a gain in clinical attachment, compared with open flap debridement by itself.
Vasundara et al7, did a prospective study on 45 year old male patient with the swelling in the upper front teeth region and large inflammatory periapical bony defect radiologically. The surgical defect was filled with with a combination of PRF and hydroxyapatite bone graft crystals The defect was covered by PRF membrane and sutured. Clinical examination revealed uneventful healing. Radiologically the HA crystals have been completely replaced by new bone at the end of 2 years. In the end of the study they concluded that the use of PRF in combination with the hydroxyapatite crystals might have accelerated the resorption of the graft crystals and would have induced rapid rate of bone formation.
Sculean et al8, in the study concluded the that the combination of barrier membrane and grafting materials may result in histological evidence of periodontal regeneration, predominantly bone repair.
Gassling et al9, proved in their study that PRF membranes are suitable for cultivation of periosteal cells for bone tissue engineering.
Pradeep et al10, in the study concluded that when hydroxyapetite is combined with PRF, it increases the regenerative effects observed with PRF in the treatment of human three wall periodontal intrabony defects.
6.3) Aim and objectives:
Aim:
To compare the efficacy of a combination of platelet rich fibrin and biograft- HT® with that of platelet rich fibrin alone in healing of mandibular third molar sockets.
Objectives:
Ø To compare the postoperative pain using a standard scale.
Ø To compare the postoperative swelling using standard measurements.
Ø To compare the postoperative trismus at various time intervals.
Ø To compare the periodontal health distal to mandibular second molar using periodontal probe at various time intervals.
Ø To compare the quality of bone healing and the formation of the new bone at the mandibular third molar socket using Intraoral periapical radiograph (IOPA) at various time intervals.
7) Materials and methods:
Pre-operatively :
· IOPA films (Kodak E- films).
· X- ray machine (Planmeca intra).
· Betadine solution and normal saline.
· Perioguard mouthwash (Colgate Palmolive INDIA LTD)
· Syringe of 10ml and 2.5ml (Dispo van).
· Centrifugal vials.
· Lignocaine hydrochloride with adrenaline (1:80000)
· Centrifugation machine.
Intra-operatively :
· Standard armamentarium for surgical removal of mandibular third molar.
· Guaze piece.
· Platelet rich fibrin (PRF).
· Biograft- HT® (An Alloplast material)
· Suturing needle and 3-0 Black braided silk (lifecare)
Postoperatively :
· Cap Mox (Amoxicillin) 500 mg thrice daily for 5 days
· Tab Voveron 50 mg (Diclofenac sodium) twice daily for 5 days
To record pain, swelling, trismus, periodontal health and bone healing and bone formation.
· Visual analog scale
· Thread
· Vernier calliper
· Williams probe
· IOPA radiograph (tracing equipments )
7.1) Source of data:
15 patients of both genders with age group 18-35 years who will report to the Department of Oral and Maxillofacial Surgery, K.V.G. Dental College, Sullia, for surgical removal of bilateral similarly impacted mandibular third molars.
7.2) Methods of data collection:
I. Definition of study subject:
15 patients between age group ranging 18-35 years, with bilateral similarly impacted mandibular lower third molar surgery will be the study subjects. Informed consent will be taken from the subjects prior to treatment.
Surgical technique
· Written informed consent will be obtained from all the patient.
· The area of the anticubital region will be prepared with the cotton and spirit.
· For the preparation of PRF, the blood will be transferred into the vial which doesn’t contain citrate phosphate dextrose (anticoagulant).
· Patient is asked to gargle with Perioguard mouthwash 10 minutes before starting the procedure.
· As the preparation requires 15- 20 minutes, in the meantime the extraction procedure is started.
· Surgical procedure will be done after draping and painting the surgical area with betadine solution.
· All the patients will be treated using 2% lignocaine Hydrochloride with adrenaline in 1:80000 concentrations
· Both right & left impacted molars will be treated by the same surgeon with a time interval of minimum 30 days.
· Incision will be given with B.P. blade no.15 and envelope flap will be used.
· After the flap reflection, bone removal will be done with straight fissure bur ( No. 702 S.S White). If required tooth sectioning will be performed.
· Once tooth is removed smoothening of bone margins, irrigation of socket with normal saline will be done. Hemostasis will be achieved.
· Platelet Rich Fibrin (PRF) and Biograft- HT® (in case of group A) or Platelet Rich Fibrin (PRF) alone (in case of group B) will be placed into the socket with the help of tweezers.
· 3 Sutures will be given with 3-0 black silk (Lifeline) after surgery.
· Immediate post-operative x- ray (IOPA) of the extraction socket will be taken.
· Post extraction instructions are given and patients are recalled for follow-up on 1st, 3rd, 7th, 14th post-operative day and also after 8th and 16th week.
· All the patients are instructed to take the following medication :
o Cap Mox (Amoxicillin) 500mg thrice daily for 5 days
o (Tab Clindamycin 600mg twice daily for 5 days in case of allergy to Penicillins)
o Tab Voveron (diclofenac sodium) 50 mg thrice daily for 5 days.
Tab Rantac 150mg (Ranitidine ) twice daily is prescribed if patient has a history of gastric irritation.
Methods of Preparation:
Method of Preparation of Platelet Rich Fibrin: The 10ml blood is drawn into test tubes without an anticoagulant and centrifuged immediately. Blood is centrifuged using a tabletop centrifuge for 12 minutes at 2,700 rpm. The resultant product consists of the following three layers:
• Top most layer consisting of acellular plasma
• PRF clot in the middle
• Red Blood Cells at the bottom
The top most layer consisting of acellular plasma is discarded with the help of pipette, because of the absence of an anticoagulant, the blood begins to coagulate as soon as it comes in contact with the glass surface. Therefore, for successful preparation of PRF, speedy blood collection and immediate centrifugation, before the clotting cascade is initiated is absolutely essential.