Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
Primary Purpose
Paresthesia, Anesthesia, Local, Neurosensory Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Platelet rich fibrin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Paresthesia
Eligibility 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
Sites / Locations
- Shiraz university of medical sciences
- Taleghani HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
treatment group
Control group
Arm Description
One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation
In control site , placebo gel will be placed before rigid fixation
Outcomes
Primary Outcome Measures
Two-point discrimination (TPD) test
Two point discrimination will be measured based on the distance of two points (mm)
Two-point discrimination
Two point discrimination will be measured based on the distance of two points (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT03159338
First Posted
May 2, 2017
Last Updated
December 6, 2017
Sponsor
Shiraz University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03159338
Brief Title
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
Official Title
The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paresthesia, Anesthesia, Local, Neurosensory Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Masking
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.
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
In control site , placebo gel will be placed before rigid fixation
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin
Intervention Description
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed
Primary Outcome Measure Information:
Title
Two-point discrimination (TPD) test
Description
Two point discrimination will be measured based on the distance of two points (mm)
Time Frame
TPD will be assessed after 6 months
Title
Two-point discrimination
Description
Two point discrimination will be measured based on the distance of two points (mm)
Time Frame
Two-point discrimination will be evaluated after12 months intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Tabrizi, DMD
Phone
+989125850829
Email
tabmed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz university of medical sciences
City
Shiraz
Country
Iran, Islamic Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Phone
09125850829
Email
tabmed@gmail.com
Phone
00987136280458
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi
Facility Name
Taleghani Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahimeh Akhlaghi, DMD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
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