Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT

Study Overview
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Brief Summary
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The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%. There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.

Official Title
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Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT

Conditions
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to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO

Intervention / Treatment
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* Procedure: bilateral sagittal split osteotomy using separators.


Participation Criteria
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Eligibility Criteria
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IInclusion criteria: Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy. Adults >18 years. Systemically healthy. Exclusion criteria: Patients not indicated for orthognathic surgery. Severe systemic disease. Have a medical condition associated with systemic neuropathy (e.g. diabetes) Patients whom cannot tolerate follow up intervals. (affect accuracy of study results) Are unwilling to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 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: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral sagittal split osteotomy using chisels.<br>The final split is completed with Smith forceps and flag separators | Procedure: bilateral sagittal split osteotomy using separators.<br>* The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurosensory disturbance of the inferior alveolar nerve. | use Von Frey filaments to test sensory function of the lower lip and two point discrimination test (blunt and sharp ) also to assess the sensory function | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bad split | if bad split in the mandible occur during the operation it will be reported | 1 year | 
| post operative edema , | preoperative measure from the tragus to mid of the chin by cm then the measure is repeated to count the amount of edema | 1 year | 
| post operative pain | by visual analogue scale from 0 to 10 and the patient choose the number | 1 year |