Clinical trial NCT03159338: Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
Official title: The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paresthesia
Anesthesia, Local
Neurosensory Disorder
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2017-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Two-point discrimination (TPD) test
timeFrame: TPD will be assessed after 6 months
measure: Two-point discrimination
timeFrame: Two-point discrimination will be evaluated after12 months intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz university of medical sciences
city: Tehran
country: Iran, Islamic Republic of
facility: Taleghani Hospital
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Reza Tabrizi, DMD
role: PRINCIPAL_INVESTIGATOR
References: