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

NCT03159338 | Unknown DMC

• 1 other identifier: 30345
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Paresthesia; Anesthesia, Local; Neurosensory Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

treatment group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Platelet rich fibrin BIOLOGICAL

Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.

treatment group

Placebo BIOLOGICAL

In control group , after spliting the osteotomy site before fixation a placebo gel will be placed

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (2)

Shiraz university of medical sciences

Shiraz, Iran

NOT YET RECRUITING

Taleghani Hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Paresthesia; Sensation Disorders

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reza Tabrizi, DMD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Tabrizi, DMD

CONTACT

+989125850829; tabmed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of oral and maxillofacial surgery

Model Details: one side of osteotomies randomally will be considered as a treatment group and another side as a control group.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 18, 2017
• Study Start: September 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

IR (2)