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

Not Applicable

• Conditions: Paresthesia; Anesthesia, Local; Neurosensory Disorder
• Interventions: Biological: Platelet rich fibrin; Biological: Placebo

• Registration Number: NCT03159338
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Study Start: 2017-09-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-07
• Primary Completion: 2018-05-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy

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Exclusion Criteria

• Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment group	Platelet rich fibrin	One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation
Control group	Placebo	In control site , placebo gel will be placed before rigid fixation

Primary Outcome Measures

Name	Time	Method
Two-point discrimination (TPD) test	TPD will be assessed after 6 months	Two point discrimination will be measured based on the distance of two points (mm)
Two-point discrimination	Two-point discrimination will be evaluated after12 months intervals	Two point discrimination will be measured based on the distance of two points (mm)

Trial Locations

Locations (2)

Taleghani Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Shiraz university of medical sciences; 🇮🇷 Shiraz, Iran, Islamic Republic of