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IRCT20210209050304N1 IRCT 2021-07-29 Shahid Beheshti University of Medical Sciences Effect of life-style on temporomandibular joint disorders Evaluation of the effect of life-style factors on temporomandibular disorders 2021-07-23 anticipated 50 Complete https://irct.ir/trial/57150 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by the simple method and with cards. Type of intervention is written on the cards which will be put in sealed opaque envelopes. Patients are included in the list of the participants in the order of the time of their first visit and the code of the questionnaire they have completed. After entering the trial, each patient chooses an envelope after folding the cards. Envelopes are prepared according to the predicted sample size and the number of patients; Therefore, each selected envelope will not be re-entered in the randomization sequence, so there would be the same number of patients in both groups. N/A Temporomandibular joint disorder. Intervention 1: Control group: They receive the routine pharmacotherapy regimen (Naproxen 250mg q8h AND Methocarbamol 500mg q8h for 2 weeks). Intervention 2: Intervention group: In addition to pharmacotherapy (Naproxen 250mg q8h AND Methocarbamol 500mg q8h for 2 weeks), they follow the following protocol: 1-listening to desired music at least 45 minutes daily 2-Walking or exercise of choice 30 minutes daily (At least 5 days a week) 3-Managing sleeping hours to a minimum of 7 hours daily (At least 5 days a week). Yes - There is a plan to make this available What will be shared: Age, sex and information on patients' life-style, without exposing their personal information and identity, and improvements on their temporomandibular disorder can be published. When: Starts after the trial is over. To whom: Researchers presenting a recommendation letter from a research center or an educational institute can access the data. Conditions: Data can be accessed and used for further research by researchers providing a recommendation letter from a research center or an educational institute. Where to obtain: Data can be obtained from the first author (Dr. Reza Tabrizi) or the oral and maxillofacial surgery department of Shahid Beheshti dental school. Contact information has been presented in the previous sections. How to obtain: After presenting a recommendation letter from a research center or an educational institute, the requested data will be presented to the researcher as soon as possible. Comments:
public Reza Tabrizi
No. 2, Nabavi Ave., Shariati Street
Tehran Iran (Islamic Republic of) 1963815971 +98 21 2267 2126 tabmed@gmail.com Shahid Beheshti University of Medical Sciences scientific Reza Tabrizi
No. 2, Nabavi Ave., Shariati Street
Tehran Iran (Islamic Republic of) 1963815971 +98 21 2267 2126 tabmed@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with Temporomandibular disorder (TMD) signs and symptoms Patients suffering from sleep disturbance Patients suffering from psychological distress no limit no limit Both Patients suffering from systemic diseases that affects the temporomandibular joint History of jaw fracture or trauma History of orthognathic surgery or other joint surgeries Patients who have an acceptable life-style M26.6 Temporomandibular joint disorders Treatment - Drugs Lifestyle Control group: They receive the routine pharmacotherapy regimen (Naproxen 250mg q8h AND Methocarbamol 500mg q8h for 2 weeks). Intervention group: In addition to pharmacotherapy (Naproxen 250mg q8h AND Methocarbamol 500mg q8h for 2 weeks), they follow the following protocol: 1-listening to desired music at least 45 minutes daily 2-Walking or exercise of choice 30 minutes daily (At least 5 days a week) 3-Managing sleeping hours to a minimum of 7 hours daily (At least 5 days a week) Joint pain. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: Visual Analogue Scale. Clicking. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: Clinical examination. Maximum Mouth Opening. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: Clinical Examination. Crepitus. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: Clinical Examination. Stress Score according to Psychological General Well-Being Index. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: Psychological General Well-Being Index. Sleep quality according to The Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the trial and on the follow up sessions; 3, 6 and 9 months after starting the intervention. Method of measurement: The Pittsburgh Sleep Quality Index Questinnaire. Shahid Beheshti University of Medical Sciences Approved 2020-11-23 Ethics committee of Research institute for Dental Sciences - Shahid Beheshti University Of Medical S 13th Fl, Block A, Ministry of Health, Treatment and Medical Education Headquarters, Between Zarafshan & South Falamak, Sima-Ye-Iran St, Qods Town Tehran Tehran Iran (Islamic Republic of)