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IRCT20210306050604N2 IRCT 2021-11-16 Yazd University of Medical Sciences Comparison of the effect of PRP and Prolotherapy on symptom control in patients with temporomandibular joint disorders Comparison of the effect of PRP and Prolotherapy on symptom control in patients with temporomandibular joint disorders 2021-10-23 anticipated 40 Complete https://irct.ir/trial/59860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using Random allocation software version 1.0 under Windows, we generate a random sequence by simple random allocation method. In this table, we specify from one to 40 and each number is assigned to an intervention group (A or B). . The first qualified person is assigned number 1, the second person is assigned number 2 and so on up to 40 patient. In order to blind the random allocation of clients by a third person who is unaware of the interventions, they are placed in intervention groups (A or B) by this table.When the eligible patient presents, based on the patient's number, the intervention group is asked by telephone by a third person. N/A Temporomandibular joint disorders. Intervention 1: Intervention group 1: For each joint, 10 cc of blood is taken from the patient's antecubital vein and transferred to sterile test tubes (BD Company-made in USA) containing sodium citrate, and after transferring the tubes to the laboratory in the shortest possible time, Centrifuge for 1 minute at 1500 rpm and 50 Hz frequency (High speed Universal - PIT320), the amount of 1.5 cc of PRP obtained is mixed with 1.5 cc of 2% lidocaine. In each painful joint, 3 cc of this solution is injected in 3 different places. Injections are done in 2 stages on days 0 and 14. Intervention 2: Intervention group 1: 0.75 ml of 50% dextrose (Shahid Ghazi Pharmaceutical CompanyMade in Iran) with 1.5 ml of 2% lidocaine (provided by Caspian Pharmaceutical Company)- Made in Iran) and 0.75 ml of normal saline are mixed and thus dextrose with a concentration of 12.5% is obtained. In patients with dextrose group, we inject 3 ml of this solution in each joint in 3 separate areas (1 ml per area). Injections are done in 2 stages on days 0 and 14. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the final conclusion, the decision is made about the publication of the data.
public Mohsen Barzegar
Non121 bahar ave Javan blvd
Yazd Iran (Islamic Republic of) 8916698436 +98 35 3820 8342 m.Barzegar@ssu.ac.ir Yazd University of Medical Sciences scientific Mohsen Barzegar
Non121 bahar ave Javan blvd
Yazd Iran (Islamic Republic of) 8916698436 +98 35 3820 8342 m.Barzegar@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) A history of chronic temporomandibular joint pain and a clicking sound in one or both sides and decreased mouth opening that started at least 3 months ago and has not responded to conservative treatment No evidence of intra-articular pathological problems on open and closed-mouth dynamic MRI Do not be allergic to corn Do not have inflammatory connective tissue disease, neurological disorders, severe anemia, thrombocytopenia or malignant diseases of the head and neck Do not have masticatory muscle problems and muscle tenderness and a previous history of open joint surgery Do not have problems with dental origin in OPG 18 years no limit Both Patients who do not agree with the injection protocol M26.6 Temporomandibular joint disorders Treatment - Drugs Treatment - Drugs Intervention group 1: For each joint, 10 cc of blood is taken from the patient's antecubital vein and transferred to sterile test tubes (BD Company-made in USA) containing sodium citrate, and after transferring the tubes to the laboratory in the shortest possible time, Centrifuge for 1 minute at 1500 rpm and 50 Hz frequency (High speed Universal - PIT320), the amount of 1.5 cc of PRP obtained is mixed with 1.5 cc of 2% lidocaine. In each painful joint, 3 cc of this solution is injected in 3 different places. Injections are done in 2 stages on days 0 and 14 Intervention group 1: 0.75 ml of 50% dextrose (Shahid Ghazi Pharmaceutical CompanyMade in Iran) with 1.5 ml of 2% lidocaine (provided by Caspian Pharmaceutical Company)- Made in Iran) and 0.75 ml of normal saline are mixed and thus dextrose with a concentration of 12.5% is obtained. In patients with dextrose group, we inject 3 ml of this solution in each joint in 3 separate areas (1 ml per area). Injections are done in 2 stages on days 0 and 14 Patient pain in temporomandibular joint. Timepoint: Days 0 (before the start of the study), 14, 30, 60, 90. Method of measurement: Visual Analogue Scale ( VAS ). Maximum mouth opening rate. Timepoint: Days 0 (before the start of the study), 14, 30, 60, 90. Method of measurement: millimetre. Joint clicking sound. Timepoint: Days 0 (before the start of the study), 14, 30, 60, 90. Method of measurement: 0: No sound-1: Subjective sound / can be heard with a stethoscope-2: A sound that can be heard without a stethoscope. Yazd University of Medical Sciences Approved 2021-11-03 Ethics committee of Shahid Sadouqi School of Yazd Dentistry Dahe Fajr Ave,Shahid Sadouqi School of Dentistry of Yazd Yazd Yazd Iran (Islamic Republic of)