Comparison of Surgical Approaches in Reducing Mandibular Angle Fracture

Study Overview
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Brief Summary
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This study compared the surgical approach to the lower jaw fractures, an approach from the face and an approach from inside the mouth were used and compared for the outcomes.

Detailed Description
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Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 Mandibular factures tend to be more common than those of the middle third of the face.1 They occur alone or in combination with other facial bone fractures resulting in severe loss of function and disfigurement.2,3 The pattern of mandibular fractures varies with geographic location, physical activity, social, cultural and environmental factors. The main causes 4,5 of mandibular fracture are; Road traffic accidents, interpersonal violence, falls, sports injuries, industrial trauma, pathological fractures etc. In developing countries road traffic accident 6 is the common cause of mandibular fractures due to lack of implementation of traffic laws while in developing countries alcohol related7 interpersonal violence is the leading cause. Any age and sex group may sustain trauma to the lower jaw but children below the age of 12 years are less susceptible to fracture because their bones are more resilient.5,6 Different modalities available for the treatment of mandibular fractures are: Maxillo mandibular fixation (MMF) alone e.g. dental wiring, arch bar etc.8 Previously traditional methods i.e. maxillomandibular fixation and transosseous wiring were the most popular methods used for mandibular fracture fixation. These are still commonly used methods9 and have got various disadvantages such as preventing normal jaw function, weight loss due to restriction of food to liquid consistency, oral hygiene problem and reduction of ventilatory volume.,10 Currently, fixation with one or two mini- plates has become a widely acceptable method of providing internal fixation and eliminating the need for post-operative maxillo mandibular fixation. The fixation of mandibular angle can be carried out by two methods i.e. Intra oral approach8, and Extra oral approach. For intra oral approach buccal sulcus incision while for extra oral approach sub-mandibular (Risdon),11 incision is given. Postoperative complications related to both types of treatment modalities were observed in intra oral approach 13.3 % and extra oral approach 16.6% infection and limited opening were observed in intra oral approach 6.6% and extra oral approach 16.6%.12 Rationale of this study is to compare post-operative complication of intra oral approach and extra oral approach in reduction of mandibular angle fracture in terms of infection and limited mouth opening. In our study, if we find less complication of intra-oral approach in significant number of patients, we will strongly recommend its routine use in the reduction of pain and limited mouth opening.

Official Title
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Comparison of Intra-oral and Extra-oral Surgical Approach in Reducing Fractures at the Angle of the Mandible

Conditions
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Fractures, Bone, Mandibular Fractures

Intervention / Treatment
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* Procedure: Maxillofacial surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 16 to 60 years Both Genders. Patients undergoing surgery for mandibular angle fracture Exclusion Criteria: Pathological fractures. Condylar and sub-condylar fractures. Edentulous patients. Fire arm injury (FAI). Fractures of the middle third of face.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial with non-probability consecutive sampling.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-Oral Surgical approach<br>The mandibular fracture was reduced using an intra-oral surgical approach. | Procedure: Maxillofacial surgery<br>* An incision on the skin over the mandible versus incision on the gingivae inside the mouth<br>|
| Experimental: Extra-Oral Surgical approach<br>An External/Facial approach was used to reduce the mandibular bone fracture. | Procedure: Maxillofacial surgery<br>* An incision on the skin over the mandible versus incision on the gingivae inside the mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indication of post-surgical infections | Redness, swelling, pain, bleeding, or any discharge | Up to three weeks | 
| Limited jaw opening | Mouth opening considered limited if the patient can only open mouth to a width of less than the width of his/her three fingers (index, middle, ring). | Up to three weeks |