RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

SYNOPSIS Subject for Dissertation

TITLE OF THE TOPIC

Comparison of 3 dimensional plate with conventional miniplate in the fixation of mandibular fractures

Guide: Dr. Umesh K. Professor and Head Department of Oral and Maxillofacial Surgery

Submitted by: DR. Mohammad Azharuddin Said Khan Rathod PG in Department of Oral and Maxillofacial Surgery

2010 Batch

AL-AMEEN DENTAL COLLEGE AND HOSPITAL

BIJAPUR RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARANATAKA

ANNEXURE – II

Proforma for Registration of Subject for Dissertation

6.1 NEED FOR STUDY: 1. NAME OF THE CANDIDATE AND : Dr. Mohammad Azharuddin Said ADDRESS (IN BLOCK LETTERS) Khan Rathod Management of maxillofacialAL-AMEEN fractures DENTAL has goneCOLLEGE through BIJAPUR- 586108 various phases of advancement in the past century. Many ingenious devices

2. wereNAME used OF forTHE the INSTITUTION treatment of mandible: fractures.AL-AMEEN DENTAL COLLEGE BIJAPUR,KARNATAKA 586108 Different methods of open reduction and internal fixation (ORIF) have

gained popularity and interest during the last 2 decades. Methods of ORIF 3. COURSE OF THE STUDY AND : MASTER OF DENTAL SURGERY have changedSUBJECT and diversified enormously(ORAL in the ANDpast fewMAXILLOFACIAL years. They have SURGERY) become smaller and simpler to handle.

4. DATE OF WhenADMISSION selecting TO aCOURSE fixation scheme: for a fracture, one has to consider 30th APRIL 2010 many things such as size, number of fixation devices, their location, ease of

adaptation and fixation, biomechanical stability, surgical approach and

5. amountTITLE of softOF THEtissue TOPIC disruption necessary “toComparison expose the fracture of 3-Dimensional and place the plate with conventional miniplate in fixation devices. the fixation of mandibular

A majority of the mandibular fractures are treatedfractures” by using standard

Champy miniplate fixation. The 3-dimensional (3D) plating system for

mandibular fracture treatment is relatively new.1

Three dimensional titanium plates and screws were developed and

reported by Farmand and Dupoirieux. Their shape is based on the principle of the quadrangle as a geometrically stable configuration for support. Because

3D stability is achieved by the geometric shape that forms cuboid, compared with standard miniplates and reconstruction plates, the thickness of these plates is reduced to 1mm. Even though The basic form of quadrangular 2-by-

2 hole plate with square and rectangular segment; 3-by-2 or 4-by-2 hole plates are also available. 1

The plates are adapted to the bone according to Champy’s principle and are secured with monocortical self cutting screws. 1

In this study, effectiveness of 3-Dimensional and standard miniplate fixation in the treatment of mandibular fractures will be evaluated. 6.2 REVIEW OF LITERATURE

1. Farmand M. (1993) 2 conducted a study to evaluate the use of 3-Dimensional plate fixation in mandibular fractures. The clinical results and biomechanical investigations of this study have shown a good stability of the 3-D-plates in the osteosynthesis of mandibular fractures without major complications. The thin 1.0 mm connecting arms of the plate allow easy adaptation to the bone without distortion. The free areas between the arms permit good blood supply to the bone.

2. Ellis E. (1993) 3 conducted a study in 52 patients with fracture of the

mandibular angle who are treated by extra-oral open reduction and internal

fixation using AO reconstruction bone plate. He concluded that the use of AO

reconstruction bone plate for fractures of the mandibular angle is found to be

very predictable and is associated with a low rate of complications.

3. Guimond C, Johnson JV and Marchena JM. (2005) 4 conducted a study to

evaluate the complication rate with the use of a 3-dimensional 2.0 mm curved

angle strut plate for mandibular angle fracture fixation. They concluded that

fixation of noncomminuted mandibular angle fractures with a 2.0 mm curved

angle strut plate was predictable.

4 Siddique A, Markose G, Moos KF, McMahon J, Ayoub AF. (2006) 5

conducted a study to compare the use of one miniplate with that of two

miniplates for the treatment of mandibular angle fractures. They concluded

that two miniplates seem to confer no extra benefit to patients, but a much

larger trial would be required to show this conclusion. 5 Zix J, Leiger O and Iizuka T. (2007) 6 conducted a study to evaluate the

clinical usefulness of a new type of 3-dimensional miniplate for open

reduction and monocortical fixation of mandibular angle fractures. They

concluded that the 3-D plating system is suitable for fixation of simple

mandibular angle fractures and is an easy to use alternative to conventional

miniplates.

6 Danda AK. (2010) 7 conducted a study to compare the postoperative

complications after fixation of mandibular angle fractures with two non

compression miniplates, in which a single plate is fixed on to the superior

border of the mandible and the other plate to the lateral aspect of the

mandible, with the standard technique of a single non-compression miniplate

fixed on to the superior border of mandible. They concluded that the use of

two non-compression miniplates for treating non-comminuted fractures of the

mandibular angle does not seem to have any advantage over the use of single

plate.

7 Jain MK, Manjunath KS, Bhagwan BK and Shah DK. (2010) 1 conducted

a study to compare 3-dimensional and standard (Champy’s) miniplate fixation

in the management of mandibular fractures and to analyze advantages and

disadvantages of one technique over the other. They concluded that Champy’s

miniplate system is a better and easier method than the 3-D miniplate system

for fixation of mandibular fractures. 6.3 OBJECTIVES OF THE STUDY

The aim of this study is to compare 3-dimensional (3D) and standard (Champy’s)

miniplate fixation in the management of mandibular fractures and analyze the

advantages and disadvantages of one technique over the other.

7. MATERIALS AND METHODS 7.1 SOURCE OF DATA:

Patients reporting to the department of Oral and Maxillofacial

Surgery, Al-Ameen Dental College and Hospital, Bijapur, with mandibular

fractures are selected.

7.2 METHOD OF COLLECTION OF DATA: (INCLUDING SAMPLING PROCEDURE IF ANY)

In this study, 50 patient presenting with mandibular fracture will be

selected

Inclusion criteria

1. Dentulous patients.

2. Symphysis and para symphysis fractures.

3. Mandibular body fractures.

4. Angle fractures.

Exclusion criteria:

1. Edentulous patients.

2. Patients having primary and mixed dentition.

3. Systemically compromised patients. METHODOLOGY

 Patients with isolated mandibular fractures involving symphysis,

parasymphysis, body or angle fracture are included.

 Preoperative infected or medically compromised patients and those not

willing for follow up are excluded.

 Patients are divided into two groups of 25 each by lottery method and are

matched for fracture site and age.

o Group 1: 3D 2 mm stainless steel plates.

o Group 2: Standard mini plates.

 All patients are given prophylactic antibiotics intravenously half an hour

before procedure.

 Procedures are performed under general anesthesia using nasal endo-

tracheal intubation.

 Following strict aseptic precautions, an appropriate intraoral or extra-oral

incision based on the site is selected.

 The fracture site is identified, reduced and after obtaining satisfactory

occlusion, temporary maxilla-mandibular fixation is placed using Erich’s

arch bar or ivy loop eyelet wiring.

 Fixation is done using either 3D 2 mm stainless plates (Group 1) or

standard miniplates (Group 2) using Champy’s principle of

osteosynthesis.

 Fixation of 3D plate is done in such a way that a horizontal bar is

perpendicular and vertical bar is parallel to the fracture line.

 In the symphysis and parasymphysis regions, upper bar is placed in the subapical position.

 To treat fractures near the mental foramen involving the mental nerve, the

plate is placed above the nerve and, to avoid injury to the dental root,

holes are drilled monocortically, directing them into the space between the

roots.

 A rectangular plate and short screws are used.

 Fracture of body is treated by placing superior bar below the roots and

inferior bar below the mental nerve.

 At the angle region, a plate is bent over the oblique line so the vertical

crossbars are aligned perpendicular to the external oblique ridge.

 A water tight wound closure is done.

 Duration of the procedure is noted. Soft diet is recommended for 6 weeks

postoperatively.

 Patients are followed for a period of 2 months at the interval of 1 week, 2

week, 4 week, 6 week and 2 months by blinded senior oral surgeon for

wound dehiscence, infection, segmental mobility, post-operative

occlusion, significant post-operative complications, and radiological

evaluation of reduction, and fixation.

 All data will be collected on a proforma and subjected to suitable

statistical analysis, and a conclusion will be drawn. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMALS? IF SO DESCRIBE BRIEFLY.

Yes,

After obtaining written consent from patients, necessary investigations are carried out namely:

 Radiological : Orthopantomograph

Mandibular occlusal view

PA view of mandible

Chest x ray

 Routine blood and urine investigations.

 Complete blood picture

ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION 7.4 IN CASE OF 7.3?

Yes

The ethical committee clearance has been obtained. 8. LIST OF REFRENCES

1. Jain MK, Manjunath KS, Bhagwan BK and Shah DK. Comparison of –Dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg 2010;68:1568-1572

2. Farmand M. the 3-D plating system in maxillofacial surgery. J Oral Maxillofac Surg 1993;51(suppl 3):166

3. Ellis E. treatment of Mandibular angle fractures using the AO reconstruction plate. J Oral Maxillofac Surg 1993;51:250-254

4. Guimond C, Johnson JV and Marchena JM. Fixation of mandibular angle fractures with a 2.0 mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg 2005;63:209-214

5. Siddique A, Markose G, Moos KF, McMahon J, Ayoub AF. One miniplates versus two in the management of mandibular angle fractures: a prospective randomized study. Br J Oral Maxillofac Surg 2007;15:223-225

6. Zix J, Leiger O and Iizuka T. Use of straight and curved 3- Dimensional titanium miniplates for fracture fixation at the mandibular angle. J Oral Maxillofac Surg 2007;65:1758-1763

7. Danda AK. Comparison of a single noncompression miniplates versus 2 noncompression miniplates in the treatment of mandibular angle fractures: a prospective, randomized clinical trial. J Oral Maxillofac Surg 2010;68:1565-1567 : 9 Signature of the Student

: 10 Remarks of the Guide

: 11 Name and Designation of

: Dr. K. UMESH M.D.S 11.1 Guide Professor and Head Department of Oral and Maxillofacial Surgery Al-Ameen Dental College and Hospital, Bijapur : 11.2 Signature

: Dr. N.M.WARAD M.D.S. 11.3 Co-Guide Asssociate Professor Department of Oral and Maxillofacial Surgery Al-Ameen Dental College and Hospital,Bijapur : 11.4 Signature

: Dr. K. UMESH M.D.S. 11.5 Head of the Professor and Head Department of Oral and Department Maxillofacial Surgery Al-Ameen Dental College and Hospital, Bijapur : 12 12.1 Remarks of the Chairman and Principal

: 12.2 Signature