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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 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. 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. We will wait at least five minutes 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.
Sponsor: Shiraz University of Medical Sciences

Current Primary Outcome:

  • Two-point discrimination (TPD) test [ Time Frame: TPD will be assessed after 6 months ]
    Two point discrimination will be measured based on the distance of two points (mm)
  • Two-point discrimination [ Time Frame: Two-point discrimination will be evaluated after12 months intervals ]
    Two point discrimination will be measured based on the distance of two points (mm)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shiraz University of Medical Sciences

Dates:
Date Received: May 2, 2017
Date Started: May 20, 2017
Date Completion: September 30, 2018
Last Updated: May 16, 2017
Last Verified: May 2017