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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03159338
Other study ID # 30345
Secondary ID
Status Recruiting
Phase N/A
First received May 2, 2017
Last updated December 6, 2017
Start date September 1, 2017
Est. completion date September 30, 2018

Study information

Verified date December 2017
Source Shiraz University of Medical Sciences
Contact Reza Tabrizi, DMD
Phone +989125850829
Email tabmed@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date September 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Platelet rich fibrin
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
Placebo
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed

Locations

Country Name City State
Iran, Islamic Republic of Shiraz university of medical sciences Shiraz
Iran, Islamic Republic of Taleghani Hospital Tehran

Sponsors (2)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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