The purpose of this study is to assess the effect of platelet-rich fibrin on nerve regeneration after bilateral sagittal split osteotomy. The studied population in this randomized clinical trial in a parallel method, is 30 patients with class II or class III skeletal deformity who are candidate for mandibular osteotomy for correction of mandibular deformity.
Patients with a history of previous trauma to the jaw; Patients who have a history of previous surgery mandibular osteotomy; patients who had genioplasty in addition to mandibular osteotomy will be excluded from the study.
The sample size will be 60 bilateral sagittal split osteotomies in two groups(each group has 30 osteotomies).
20 cc blood was taken from each patient. Then blood is centrifuged in 1800 rpm. Platelet rich plasma is mixed with 1 cc Gloconate calcium to prepare platelet rich fibrin.
Platelet rich fibrin will be used in one osteotomy side(group 1) during surgery and another side will be considered as a control side(group 2). Selection of study side will be based on randomization
Evaluation of lower lip anesthesia is performed at intervals of 6 months and a year. Evaluation of anesthesia will be performed by the third observer without informing of the control or treatment side. All the patients are unaware of the treatment and control side .All surgeries is done by one surgeon and one surgical and fixation procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122631571N1
Registration date:2017-09-05, 1396/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-05, 1396/06/14
Registrant information
Name
Reza Tabrizi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2307
Email address
pourdanesh_f@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The study is supported by Research Department of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2018-09-30, 1397/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of platelet-rich fibrin on nerve regeneration after bilateral sagittal split osteotomy of the mandible
Public title
The effect of Platelet-rich fibrin on anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with classII or classIII skeletal deformity who are candidate for mandibular osteotomy for correction of mandibular deformity.
exclusion criteria:patients who use anti deppresant drugs;Patients with a history of previous trauma to the jaw;Patients who have a history of previous surgery mandibular osteotomy;patients who had genioplasty in addition to mandibular osteotomy.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
Clinicaltrial.gov
Secondary trial Id
NCT03159338
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
velenjak,daneshju Blv.
City
tehran
Postal code
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.SBMU.RIDs.REC.1395.249
Health conditions studied
1
Description of health condition studied
anesthesia caused by sagittal osteotomy in patients with class II and III deformity
ICD-10 code
S04.3
ICD-10 code description
Injury of trigeminal nerve
Primary outcomes
1
Description
amount of displacement of the jaw
Timepoint
during surgery
Method of measurement
mm
Secondary outcomes
1
Description
lower lip anesthesia
Timepoint
Every 6 months and a year
Method of measurement
Based on distance of two detectable points on the the lip in mm.
Intervention groups
1
Description
In intervation group(the studied side)platelet-rich fibrin produced from patient's blood is used.20 cc of the patient blood is centrifuged for 14 minutes at a speed of 28,000 rpm. The middle solution between plasma and RBC is separated after a 5 minute respite and is mixed with 1cc calcium gloconate.A gelatinous substance is prepared after 15 minutes.This substance is placed between two osteotomy pieces on Inferior Alveolar Nerve before the fixation .
Category
Treatment - Drugs
2
Description
In control group(the opposite side) fixation is done without any substance.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Reza Tabrizi
Street address
Arabi St., Daneshju Blv., Velenjak
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
6th floor, Building No. 2, Shahid Beheshti University of Medical Sciences, Daneshju Blv., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Reza Tabrizi
Position
OMFS Microvascular Fellowship
Other areas of specialty/work
Street address
Daneshju Blv., Velenjak
City
Tehran
Postal code
Phone
+98 21 2990 2307
Fax
Email
Rtabrizi@sbmu.ac.irtabmed@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Reza Tabrizi
Position
OMFS Microvascular Fellowship
Other areas of specialty/work
Street address
Daneshju Blv., Velenjak
City
Tehran
Postal code
Phone
+98 21 2990 2307
Fax
Email
Rtabrizi@sbmu.ac.ir tabmed@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ُُSaba Jafari
Position
Student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
j.saba92@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)