RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,
BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS(In Block Letters) / DR. GAURAV MALIK
POST GRADUATE STUDENT,
DEPARTMENT OF ORAL, MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY,
BAPUJI DENTAL COLLEGE AND HOSPITAL,
DAVANGERE- 577004
KARNATAKA.
2 / NAME OF THE
INSTITUTION / BAPUJI DENTAL COLLEGE AND HOSPITAL,
DAVANAGERE- 577004
3 / COURSE OF THE
STUDY AND THE
SUBJECT / MASTER OF DENTAL SURGERY IN
ORAL AND MAXILLOFACIAL SURGERY
4. / DATE OF ADMISSION TO COURSE / 21st MAY, 2012
5 / TITLE OF THE DISSERTATION / “EVALUATION OF OSTEOSYNTHESIS OF MINIPLATE VERSUS LAG-SCREW IN MANAGEMENT OF MANDIBULAR ANGLE FRACTURE - A COMPARATIVE STUDY.”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
The mandibular angle fracture treatment is done to restore the anatomical form and function with particular care to establish the occlusion. The angle of the mandible is the second most frequent region for fractures caused by alleged assaults and the third most fractured region in case of falls. Towards the end of the 1980’s, a clear change appeared in fracture treatment. In the course of this decade, the type of osteosynthesis changed from wire and miniplates to compression plates and lag screws. Although there is a widely accepted consensus about the need for surgical reduction and fixation of mandibular angle fracture, a variety of different treatment modalities have been described. Extra oral open reduction and internal fixation with a reconstruction plate, Intraoral open reduction and internal fixation using different mini-dynamic compression or non compression plates, and fixation with lag screw. Lag screw fixation is a safe, effective and inexpensive method that has number of advantages over plate osteosynthesis. The principle of lag screw is based on axial compression between the fragments. The screw glides through the fragment located near the screw head and seize the fragment located distant from the screw head. Less implant material is required in lag screw technique as compared to miniplate technique. Besides supplying compression between the fragments it supports healing, fracture stabilization is firm, tissue exposure is reduced and it can be applied more rapidly.1
Thus the aim of this study will be to evaluate osteosynthesis of miniplate versus lag screw in the management of mandibular angle fracture.
Research hypothesis: - There is difference between the osteosynthesis of miniplate versus lag screw in the management of mandibular angle fracture.
Null hypothesis: - There is no difference between the osteosynthesis of miniplate versus lag screw in the management of mandibular angle fracture.
6.2 Review Of Literature :
A retrospective study was conducted on 50 patients to evaluate the efficacy of solitary lag screw osteosynthesis in treatment of fracture of angle of mandible. Patients were followed for two months for infection, postoperative anaesthesia, occlusion, radiographically for checking positioning of fragments. The data showed that procedure was an effective and predictable modality of treatment with low degree of morbidity.2
A study was conducted prospectively on 81 patients to evaluate the results in treatment for the fracture of mandibular angle with single noncompression miniplate with 2.0 mm self threading screws placed through a transoral incision. No patient was placed into postsurgical maxillomandibular fixation. They were prospectively studied for complications. Most of complications were minor and could be treated in office. The authors concluded that single miniplate for the fractures of angle of mandible is simple, reliable techniques with a relatively small number of major complications.3
A prospective study was conducted to evaluate clinical and radiologic results after lag screw fixation of mandibular parasymphseal and angular fractures. All the patients were evaluated for infection, malocclusion, post operative neurosensory deficits. The results of this study showed that lag screw fixation of mandibular fractures is a practical and effective way of treating such fractures internally. It leads to good bone healing without permanent neurosensory deficit or increased risk of malocclusion.4
A study was conducted on 45 patients to compare miniplate versus lag-screw osteosynthesis for fractures of the mandibular angle. The main parameters for the outcome analysis were fracture gaps at four defined measuring points on postoperative radiography. Postsurgical complications were recorded. Miniplate fixation resulted in a wider fracture gap, especially in the region of lower margin of mandible. In conclusion lag screw fixation demonstrated smaller fracture gap compared with miniplate fixation.1
A comparative prospective study was conducted on 30 patients diagnosed as cases of displaced mandibular anterior fractures to compare the outcome of open treatment of mandibular fracture (symphysis or parasymphysis) using lag screw or miniplate clinically as well as radiologically. All the patients were evaluated for infection, malocclusion, loosening of plate/screw, sensory disturbance, plate fracture, malunion/non-union, devitalisation of associated dentoalveolar segment and masticatory efficiency. They concluded that the application of lag screw is an effective, inexpensive, quick treatment modality to accelerate healing of fresh, displaced mandibular anterior fracture.5
6.3 Objectives Of The Study :
· To compare the standardized miniplate and lag-screw fixation in the management of mandibular angle fractures, and to analyze the advantages and disadvantages of one over the other.
· To prospectively evaluate the efficacy of osteosynthesis using single miniplate or lag screw for stabilization of fracture of mandible.
7. / MATERIALS AND METHODS :
7.1 Source of Data :
A total of 30 patients involving mandibular angle fracture reporting to the Department of Oral, Maxillofacial and Reconstructive Surgery, Bapuji Dental College and Hospital, Davangere.
Inclusion criteria :
1) Isolated mandibular angle fracture / multiple fractures of mandible involving the angle.
2) Patients willing for follow up.
3) Patients who come under ASA I category.
Exclusion criteria:
1) Comminuted fractures of mandible
2) Fracture in pediatric mandible.
3) Pre-operative infected patients.
4) Fracture in edentulous mandible.
5) Patients not willing to return for follow up.
7.2 Methods of collection of Data :
After obtaining ethics and research committee approval, informed and written consent will be obtained, patients of both genders with isolated mandibular angle
fracture or multiple fractures involving angle of mandible will be included. Patient will be divided in to two groups of 15 each randomly for managing angle fracture of mandible.
Group-A (miniplate group) patients undergoing treatment of angle fracture of mandible using standardized miniplate. and Group-B (lag screw group) patients undergoing treatment of angle fracture of mandible using lag screw.
A standardized data sheet will be formulated and demographic variables and relevant clinical and radiological finding will be noted. Procedures will be carried out under general anesthesia with strict aseptic precautions.
In Group-A an appropriate intraoral/extra oral incision will be selected. Fracture site will be identified, reduced, and after obtaining satisfactory occlusion, temporary maxillomandibular fixation will be placed using either Erich’s arch bar or Ivy loop eyelet wiring. Fixation will be done using standardized miniplate.
In Group-B an intraoral incision will be given to visualize fracture line. The occlusion will be restored and fragments will be anatomically coapted by manual repositioning. Interposed soft tissue must be freed from the fracture line to avoid delayed healing. Bone holding clamps and intermaxillary wires are used to immobilize fragments. A transcutaneous stab incision will be given at the level of premolars and the border of mandible. A drill bit protected by drill sleeve will be used to drill a gliding hole in distal fragment. The drilling is begun in the outer cortical plate at very acute angle to bone surface usually at the level of external oblique ridge. The hole is drilled caudolateral to craniolingual. When bore in distal fragment is finished. A Hole
is drilled further along predetermined axis into proximal fragment until it penetrates the inner cortical bone. After the holes in both fragments are finished a cortical bone screw is now used. By firmly tightening screw, fracture surfaces are stabilized under pressure. The lag screws run obliquely through body of mandible in anterioposterior direction. It enters the body approximately in the region of 1st molar at the level of external oblique ridge and exit medially, anterior to the mandibular foramen.
Radiological evaluation will be done using standardized Orthopantomogram and Reverse Town’s view. On the radiographs a line along the fracture line will be drawn and will be divided into three equal parts. Measurement of fracture gap between the fracture fragments will be done at four defined points on that line.
In case of multiple mandibular fractures, the osteosynthesis will be performed from mesial to distal fractures e.g. in midline and angle fracture, the midline fracture will be fixed first, followed by the angle fracture.
In both the groups watertight wound closure will be achieved. Duration of the procedure will be noted. Soft diet will be recommended for 6 weeks postoperatively. The patients will be followed for a period of 2 months at the interval of 1 week, 2 weeks, 4 weeks, and 8 weeks by a senior oral surgeon. All patients will be evaluated for the following criteria:-
1. Infection.
2. Segmental mobility.
3. Postoperative occlusion.
4. Duration of the procedure.
5. Radiological evaluation of reduction and fixation using standardized Orthopantomogram and Reverse Towne’s view.
Sample size determination:
Based on the available information (from previous studies and experience),
A sample size is determined based on the estimated effect size of 1.1
α i.e. type-I error (level of significance) = 5%
β i.e. type-II error =20%
Power of the study =80%
Referring to standard Cohen’s d table.
Required sample size =15 cases in each group.
Statistical analysis:-
Results will be subjected for appropriate analysis; Categorical data will be analyzed by unpaired-t test (if it is normally distributed) or Mann-Whitney U test (if not normally distributed).
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes,
a) Radiographic investigations.
b) Routine blood and urine investigations.
c) Surgical intervention under general anesthesia.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
· Yes, it has been obtained and is enclosed herewith.
8 / LIST OF REFERENCES :-
1. Schaaf H, Kaubregge S, Streckbein P, Wilbrand J, Kerkmann H, Howalt HP. Comparision of miniplate versus lag-screw osteosynthesis for fractures of mandibular angle. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011;111:34-40.
2. Niederdellmann H, Shetty V. Solitary lag screw osteosynthesis in the treatment of fractures of angle of mandible. Plast Reconstr Surg. 1987;80:68-74.
3. Ellis E III, Walker LR. Treatment of mandibular angle fractures using one non compression miniplate. J Oral Maxillofac Surg. 1996;54:864-71.
4. Kallela I, Ilzuka T, Laine P, Lindqvist C. Lag-screw fixation of mandibular parasymhyseal and angle fractures. Oral Surg Oral med Oral Pathol Oral Radiol Endod. 1996;81:510-6.
5. Bhatnagar A, Bansal V, Kumar S, Mowar A. Comparative Analysis of Osteosynthesis of Mandibular Anterior Fractures Following Open Reduction Using Stainless Steel Lag Screws and Mini Plates. J Maxillofac Oral Surg. 2012 Aug;10.1007/s12663-012-0397-z.
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE
DEPARTMENT OF ORAL, MAXILLOFACIAL AND RECONSTRUCTIVE SURGERY
“EVALUATION OF OSTEOSYNTHESIS OF MINIPLATE VERSUS LAG-SCREW IN MANAGEMENT OF MANDIBULAR ANGLE FRACTURE - A COMPARATIVE STUDY.”
Name of the investigator: Guided by :
Dr. Gaurav Malik Dr. Umashankar K. V.
Post graduate student Professor
INFORMED CONSENT:
I have been informed about the objectives of this study along with its advantages and disadvantages. It has been assured to me that the details obtained during the course of the study will be kept confidential. Hence, I volunteer myself to participate in the study.
Name of the Patient
Signature
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PATIENT INFORMATION FORM
I, Dr. Gaurav Malik, post -graduate student in the Department of of Oral, Maxillofacial and Reconstructive Surgery, Bapuji Dental College and Hospital, Davangere, am conducting a study on “EVALUATION OF OSTEOSYNTHESIS OF MINIPLATE VERSUS LAG-SCREW IN MANAGEMENT OF MANDIBULAR ANGLE FRACTURE - A COMPARATIVE STUDY.” You will be given complete information about the research. I assure you that the details obtained during the course of study will be kept confidential and will not revealed to anyone. You are free to decide anytime whether you want to participate in the study or not after going through the information given to you. The research procedure involves fixing the mandibular angle after reduction either with a lag screw or a standardized non compression miniplate. If you have any questions you are always free to ask. You will not be compensated by any means for participating in this study. If you are not interested to participate or if you feel uncomfortable, you can withdraw or refuse for the same at any time.
NAME AND ADDRESS OF PRINCIPAL INVESTIGATOR:
Dr. GAURAV MALIK.
Post- graduate student,
Room no. 2,
Department of Oral, Maxillofacial and Reconstructive surgery
Bapuji Dental College and Hospital,
Davangere.
Mobile number: 89519-96360
If you experience any grievances while participating in this study, feel free to call any of the following numbers:
Dr. K. Sadashiva Shetty: 08192-220575
(Member Secretary, Institutional Review Board)
Dr. L. Nagesh : 99844-03547
(Member, Institutional Review Board)
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