Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy

Study Overview
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Brief Summary
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Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.One side of the osteotomies randomly will be considered as study group and another side as a control group.In the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.In the control group, fixation will be done without Platelet-rich Fibrin (PRF).Neurosensory disturbance will be evaluated 6 and 12 months after surgeries.

Detailed Description
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Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.One side of the osteotomies randomly will be considered as study group and another side as a control group.In the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.In the control group fixation will be done without Platelet-rich Fibrin. Before starting the surgical procedure, 20 mL of venous blood will take and placed in a centrifuge for 12 minutes with 28000rpm. After centrifugation, the cap will be removed from each tube and they will be placed into a sterile rack L-PRF™. Fibrin matrix will prepare. The L-PRF™ will be removed from the tube. Then, the clot right beneath the red blood cell clot will be placed on the surface tray and covered. Five minutes will be waited before removing and using the fibrin matrix.Neurosensory disturbance will be evaluated in 6 and 12 months after osteotomies by two-point discrimination (TPD) test and pin tactile discrimination(PTD) tests.

Official Title
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The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible

Conditions
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Paresthesia, Anesthesia, Local, Neurosensory Disorder

Intervention / Treatment
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* Biological: Platelet rich fibrin
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy Exclusion Criteria: Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Interventional Model Description: one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation | Biological: Platelet rich fibrin<br>* Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.<br>|
| Placebo Comparator: Control group<br>In control site , placebo gel will be placed before rigid fixation | Biological: Placebo<br>* In control group , after spliting the osteotomy site before fixation a placebo gel will be placed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-point discrimination (TPD) test | Two point discrimination will be measured based on the distance of two points (mm) | TPD will be assessed after 6 months | 
| Two-point discrimination | Two point discrimination will be measured based on the distance of two points (mm) | Two-point discrimination will be evaluated after12 months intervals |