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IRCT20150613022697N6 IRCT 2018-11-22 Mashhad University of Medical Sciences The comparison of treatment success rate of injection of hyaluronic acid versus PRP 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. 2018-10-12 anticipated 30 Complete https://irct.ir/trial/32466 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The randomized double-blinded clinical trial without the placebo, Randomization description: Simple individual randomization using the table of random numbers would be used. Allocation concealment of random codes would be carried out, 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. 2 Temporomandibular joint osteoarthritis. Intervention 1: Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc hyaluronic acid. Intervention 2: Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc PRP (Platelet rich plasma). Intervention 3: Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc Hyaluronic acid combination with PRP. Yes - There is a plan to make this available What will be shared: All collected unindetified data would be shared for all researchers. When: The access to data will be started 6 months after publication. To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission. Comments:
public Sahand Samiee rad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samiee rad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 15 years 60 years Both 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 M26.6 Temporomandibular joint disorders Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc hyaluronic acid Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc PRP (Platelet rich plasma). Intervention group: arthroscopic arthrocentesis with intra-articular injection of 1cc Hyaluronic acid combination with PRP Maximum Mouth Opening (MMO) rate. Timepoint: One day before, 1, 3, 6 and 12 months after arthrocentesis. Method of measurement: Ruler in millimeters. Jaw protrusive movement rate. Timepoint: One day before, 1, 3, 6 and 12 months after arthrocentesis. Method of measurement: Ruler in millimeters. Jaw lateral Movement rate. Timepoint: One day before, 1, 3, 6 and 12 months after arthrocentesis. Method of measurement: Ruler in millimeters. Joint sounds presence. Timepoint: One day before, 1, 3, 6 and 12 months after arthrocentesis. Method of measurement: Yes / No. Joint pain amount. Timepoint: One day before, 1, 3, 6 and 12 months after arthrocentesis. Method of measurement: VAS scale. Mashhad University of Medical Sciences Approved 2018-09-12 Ethics committee of Mashhad university of medical sciences Ghoreishi building, Daneshghah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)