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

Shiraz University of Medical Sciences

Status: Unknown

Conditions: Paresthesia; Neurosensory Disorder; Anesthesia, Local

Treatments: Biological: Placebo; Biological: Platelet rich fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03159338

30345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

treatment group

Active Comparator group

Description:

One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation

Treatment:

Biological: Platelet rich fibrin

Control group

Placebo Comparator group

Description:

In control site , placebo gel will be placed before rigid fixation

Treatment:

Biological: Placebo