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

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ClinicalTrials.gov Identifier: NCT03159338
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Paresthesia Anesthesia, Local Neurosensory Disorder Biological: Platelet rich fibrin Biological: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Masking: Single (Participant)
Masking Description: Investigator will be blunt about side of treatmen and control.None of surgical team will be as an investigator.Patients will unware about which side is treatment or control.
Primary Purpose: Treatment
Official Title: The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : September 30, 2018

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




Primary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159338


Contacts
Contact: Reza Tabrizi, DMD +989125850829 tabmed@gmail.com

Locations
Iran, Islamic Republic of
Shiraz university of medical sciences Not yet recruiting
Shiraz, Iran, Islamic Republic of
Contact: Reza Tabrizi, DMD    09125850829    tabmed@gmail.com   
Contact    00987136280458      
Principal Investigator: Reza Tabrizi         
Taleghani Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Fahimeh Akhlaghi, DMD         
Sponsors and Collaborators
Shiraz University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Reza Tabrizi, DMD Shiraz University of Medical Sciences

Responsible Party: Reza Tabrizi, Assistant professor of oral and maxillofacial surgery, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03159338     History of Changes
Other Study ID Numbers: 30345
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Paresthesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms