Anesthesia, Local, Neurosensory Disorder, Paresthesia
Conditions
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.
Interventions
BIOLOGICALPlatelet rich fibrin
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
BIOLOGICALPlacebo
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed
Sponsors
Shahid Beheshti University of Medical Sciences
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-point discrimination | Two-point discrimination will be evaluated after12 months intervals | Two point discrimination will be measured based on the distance of two points (mm) |
| Two-point discrimination (TPD) test | TPD will be assessed after 6 months | Two point discrimination will be measured based on the distance of two points (mm) |
Countries
Iran
Contacts
Primary ContactReza Tabrizi, DMD
Outcome results
None listed