The comparison of treatment success rate of arthroscopic arthrocentesis by injection of PRP versus hyaluronic acid (single or combinative) for patients with TMJ osteoarthritis.
The comparison of treatment success rate of arthroscopic arthrocentesis by injection of PRP versus hyaluronic acid (single or combinative) for patients with TMJ osteoarthritis.
Design
The randomized double-blinded clinical trial without the placebo.
Patients and the assessor of the outcome would be blind to the study.
The assessor would be another surgeon who is blind to the study.
Settings and conduct
Mashhad dental school, oral and maxillofacial department
Participants/Inclusion and exclusion criteria
All of the patients with TMJ osteoarthritis (in one or both Joints) with age range 15-60 years old who received conservative treatment; patients with ASA 1 or 2 status; patients without allergy to HA and PRP; patients without history of cardiovascular or Coagulation problems; Patients without any TMJ surgery; patients without a history of neurological, immunologic head & neck and TMJ malignancy; patients Without history of problem in connective tissue such as rheumatoid arthritis
Intervention groups
Arthroscopic arthrocentesis will be performed in 3 interventional groups.
Intervention group 1: Intra-articular injection of hyaluronic acid.
Intervention group 2: Intra-articular injection of PRP (Platelet rich plasma).
Intervention group 3: Intra-articular injection of combiation hyaluronic acid and PRP.
No control group is available in this study.
Main outcome variables
Joint sounds, Joint pain, Maximum Mouth Opening (MMO), protrusive and lateral movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022697N6
Registration date:2018-11-22, 1397/09/01
Registration timing:registered_while_recruiting
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Sahand Samiee rad
Name of organization / entity
mashhad dental school,oral and maxillofacial department
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 7289
Email address
samieerads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of treatment success rate of arthroscopic arthrocentesis by injection of PRP versus hyaluronic acid (single or combinative) for patients with TMJ osteoarthritis.
Public title
The comparison of treatment success rate of injection of hyaluronic acid versus PRP for patients with TMJ osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the patients with TMJ osteoarthritis (in one or both Joints) with age range 15-60 years old who received conservative treatment.
Patients with ASA 1 or 2 status
Patients with normal cardiovascular or coagulation system
Exclusion criteria:
Patients with previous TMJ surgery
Patients with the history of neurological, immunologic head & neck and TMJ malignancy
Patients with the history of problem in connective tissue such as rheumatoid arthritis
Patients with the history of NSAIDS usage.
Patients with the allergy to HA and PRP
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using the table of random numbers would be used.
Allocation concealment of random codes would be carried out.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the assessor the outcome would be blind to the study.
The assessor would be another surgeon who is blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features
The randomized double-blinded clinical trial without the placebo
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Ghoreishi building, Daneshghah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.058
Health conditions studied
1
Description of health condition studied
Temporomandibular joint osteoarthritis
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Maximum Mouth Opening (MMO) rate
Timepoint
One day before, 1, 3, 6 and 12 months after arthrocentesis
Method of measurement
Ruler in millimeters
2
Description
Jaw protrusive movement rate
Timepoint
One day before, 1, 3, 6 and 12 months after arthrocentesis
Method of measurement
Ruler in millimeters
3
Description
jaw lateral Movement rate
Timepoint
One day before, 1, 3, 6 and 12 months after arthrocentesis
Method of measurement
Ruler in millimeters
4
Description
Joint sounds presence
Timepoint
One day before, 1, 3, 6 and 12 months after arthrocentesis
Method of measurement
Yes / No
5
Description
Joint pain amount
Timepoint
One day before, 1, 3, 6 and 12 months after arthrocentesis
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc hyaluronic acid
Category
Treatment - Surgery
2
Description
Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc PRP (Platelet rich plasma).
Category
Treatment - Surgery
3
Description
Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc Hyaluronic acid combination with PRP
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Sahand samiee rad
Street address
Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176813111
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeed Eslami
Street address
Ghoreishi building, Daneshghah avenue.
City
mashhad
Province
Razavi Khorasan
Postal code
91779448959
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
eslamis@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
30
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
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samiee rad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negin Vatanparast
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3843 1448
Fax
+98 51 3882 9500
Email
Negin.vatanparast@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected unindetified data would be shared for all researchers.
When the data will become available and for how long
The access to data will be started 6 months after publication.
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission.