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

NCT ID: NCT03159338

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Paresthesia Anesthesia, Local Neurosensory Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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treatment group

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

Group Type ACTIVE_COMPARATOR

Platelet rich fibrin

Intervention Type BIOLOGICAL

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

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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Platelet rich fibrin

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Tabrizi

Assistant professor of oral and maxillofacial surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Tabrizi, DMD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

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Shiraz university of medical sciences

Shiraz, , Iran

Site Status NOT_YET_RECRUITING

Taleghani Hospital

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Reza Tabrizi, DMD

Role: CONTACT

Phone: +989125850829

Email: [email protected]

Facility Contacts

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Reza Tabrizi, DMD

Role: primary

Role: backup

Fahimeh Akhlaghi, DMD

Role: primary

Other Identifiers

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30345

Identifier Type: -

Identifier Source: org_study_id