Evaluation of PRP (platelet rich plasma)effect on Temporomandibular disorders(TMD)
Design
Two arm parallel group randomised trial
Settings and conduct
All the patients refering to maxillofacial surgery department of Azad Dental School and Bouali Hospital with:pain,limitation in movement,goint sounds,deviation of mandible in mouth opening
Participants/Inclusion and exclusion criteria
nclusion criteria:PainLimitation in movement,Joint sounds,Deviation of mandible in mouth opening
Exlusion criteria:Systemic deases,Patients candidated for temporomandibular joint(TMJ) surgery,Disk displacement without reduction
Intervention groups
PRP injection in one side(TMJ) and the other side as witness
Main outcome variables
Decrease in pain,Limitation in movement,Joint sounds,Deviation of mandible in mouth opening of patients despite effectivness of PRP injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180503039510N1
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Mehdi Sezavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 1107
Email address
m_sezavar@dental.iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of PRP on temporomandibular disorder( TMD)
Public title
Evaluation of effect of PRP on TMD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain
Limitation in movement
Joint sounds
Deviation of mandible in mouth opening
Exclusion criteria:
Systemic deases
Patient candidate for tmj surgery
Disk displacement without reduction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left temporomandibular joint( TMJ)
Randomization (investigator's opinion)
Not randomized
Randomization description
Choosing one tmj as witness and the other one as case
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Azad Dental School
Street address
No.5 ,9 th Neyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1913633151
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,50
Health conditions studied
1
Description of health condition studied
Temporomandibular disorder(TMD)
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Temporomandibular jointPain
Timepoint
At the begining of study and 2,4 and 6 month later
Method of measurement
Visual Analogue Scale questionarie
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PRP injection in temporomandibular joint of one side in included patients(20 patients are being studie)6CC of patients blood will be transfused into sterile tubes coated with anti coagulant made by CHOUKRON company and centrifuged for3 minutes with1600 r/min,after formation of 3 layers in the tube ,the middle layer including platelet rich plasma or PRP is extracted,then a line is drwn joining the tragus to the lateral canthus(in the side to be injected),0.6 ml is injected in the point 10mm anterior to tragus (in the drawn line) and 2mm below,soft diet until one week is suggested to patient . index including pain,mouth opening,joint souds and jaw deviation in opening will be registered just at the time of injection and 2,4 and 6 months later and documented in related forms.
Category
Treatment - Other
2
Description
Control group: The temporomandibular joint in the side which has not been injected PRP,whitout any additional procedure, is considered as control group,and the indexes pain, limitation in joint movement,joint sound and deviation of mandible in opening at the begining of study and 2,4 and six months later the as intervention side is registered and finally compared with intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial department of Bouali Hospital
Full name of responsible person
Mehdi Sezavar
Street address
Bouali Hospital ,Damavand Ave
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3331 1107
Email
M_sezavar@dental.iau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzin Sarkarat
Street address
No 5, 9thNeyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1913633151
Phone
+98 21 2256 4571
Email
M_sezavar@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Sezavar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5, 9thNeyestan , Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1913633151
Phone
+98 21 2256 4571
Email
M_sezavar@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Sezavar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5, 9th Neyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1913633151
Phone
+98 21 3331 1107
Email
M_sezavar@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Sezavar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5, 9th Neyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1913633151
Phone
+98 21 3331 1107
Email
M_sezavar@dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available