An interventional study of Platelet rich fibrin and Placebo in Paresthesia, Anesthesia, Local and Neurosensory Disorder, sponsored by Shiraz University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
66 studies on the registry are indexed under Paresthesia; 14 are open to participants now.
This study's planned enrollment of 25 is below the median of 48 across 52 interventional studies indexed under Paresthesia.
Browse Paresthesia studies →Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
In control site , placebo gel will be placed before rigid fixation
Biological: Placebo
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed
Two-point discrimination (TPD) test
Two point discrimination will be measured based on the distance of two points (mm)
Time frame: TPD will be assessed after 6 months
Two-point discrimination
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for May 2018, 8 months after the start.
Of 18 interventional studies with no phase under Paresthesia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: P-prf
Shiraz University of Medical Sciences →