Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

Study Overview
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Brief Summary
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Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Detailed Description
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Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Official Title
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Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures

Conditions
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Mandible Fracture

Intervention / Treatment
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* Procedure: 2.0 single locking miniplates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions. Fractures amenable to treatment using intra oral approach. Exclusion Criteria: Medically compromised patients who are unfit for the procedure under general anesthesia. Patients with comminuted fractures. Patients with history of occlusion disturbances or skeletal malocclusion. Patients with insufficient dentition to reproduce occlusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locking miniplate<br>The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. | Procedure: 2.0 single locking miniplates<br>* The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.<br>|
| Experimental: Non-locking miniplates<br>The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. | Procedure: 2.0 single locking miniplates<br>* The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biting force | Biting force will be measured using occlusal biting force meter (Higher biting force record is better) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of fractured segments | Bi-manual manipulation (Binary Yes/No) | 6 weeks | 
| Pain intensity | Visual analog scale (0-10) 0=No pain & 10=Severe pain | 10 days | 
| Occlusion | Clinical examination (Intact/Deranged) | 6 months | 
| Infection | Clinical examination (Present/Absent) | 6 months | 
| Hardware failure | Clinical examination (Present/Absent) | 6 months | 
| Paraesthesia | Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation | 6 months | 
| Wound dehiscence | Clinical examination (Present/Absent) | 6 months |