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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03159338
• Other study ID #: 30345
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: December 6, 2017
• Start date: September 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2017
• Source: Shiraz University of Medical Sciences
• Contact: Reza Tabrizi, DMD
• Phone: +989125850829
• Email: tabmed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Neurosensory Disorder
• Paresthesia

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz university of medical sciences	Shiraz
Iran, Islamic Republic of	Taleghani Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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