NCT03159338

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Paresthesia
• Anesthesia, Local
• Neurosensory Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Platelet rich fibrin	Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
BIOLOGICAL	Placebo	In control group , after spliting the osteotomy site before fixation a placebo gel will be placed

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-05-30
• Completion: 2018-09-30
• First posted: 2017-05-18
• Last updated: 2017-12-07

Locations

2 sites across 1 country: Iran