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

December 6, 2017 updated by: Reza Tabrizi, Shiraz University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Shiraz, Iran, Islamic Republic of
        • Not yet recruiting
        • Shiraz University of Medical Sciences
        • Contact:
          • Phone Number: 00987136280458
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Taleghani Hospital
        • Contact:
          • Fahimeh Akhlaghi, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: treatment group
One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation
Biological: Platelet rich fibrin
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
PLACEBO_COMPARATOR: Control group
In control site , placebo gel will be placed before rigid fixation
Biological: Placebo
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
TPD will be assessed after 6 months
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)
Two-point discrimination will be evaluated after12 months intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Reza Tabrizi, DMD, Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ANTICIPATED)

May 30, 2018

Study Completion (ANTICIPATED)

September 30, 2018

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (ACTUAL)

May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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