A Phase 4 interventional study of Dexketoprofen Trometamol + Thiocolchicoside and Dexketoprofen Trometamol + Paracetamol in Temporomandibular Disorder, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Yuzuncu Yıl University · Phase 4, Interventional, and Treatment
The most important step in the treatment of TMJ (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. The clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the Treatment of Temporomandibular Joint Disorders. In this context, it is thought that studies in the field of dentistry should be increased in order to increase the success in the treatment of TMJ Disorders. The aim of the study is to evaluate the efficacy of of different pain relievers as Dexketoprofen Trometamol + Thiocolchicoside, dexketoprofen trometamol + paracetamol and Dexketoprofen Trometamol in the treatment of pain in TMJ disorders.
The study was carried out on 200 patients aged 18 and over, who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, with complaints of pain due to temporomandibular disease. When patients first applied to the clinic, their anamnesis were taken and they were directed to MR (Magnetic Resonance) imaging after clinical evaluation. Patients who meet the inclusion criteria and volunteer were included in the study. Patients were randomly divided into 4 groups. Medications were given to patients by auxiliary staff and the study was double-blind. Medicines were given as follows. Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg, 2x1) in the 1st group, Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1) in the 2nd group, only Dexketoprofen Trometamol (25mg, 2x1) in the 3rd group and paracetamol 500 mg in the 4th control group (4x1) were given. In addition, patients in each group used occlusal plate for a minimum of 8 hours per day (at night). Medicines were used regularly for 2 weeks. Paracetamol 500 mg was used only if needed for the next 2 weeks. The pain values of the patients was evaluated with the VAS scale, and the amount of mouth opening was evaluated by measuring the distance between the incisal edges of the lower and upper central teeth. Evaluations have been done at the beginning of the treatment and at the 1st week, 2nd week, 1st month and the 3rd month and the findings were recorded. After the 1st month, the patients were followed up to the 3rd month and the treatment of those who need additional treatment were continued. Obtained data will be analyzed and evaluated statistically.
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's enrollment of 200 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
(25mg + 4mg, 2x1)
Drug: Dexketoprofen Trometamol + Thiocolchicoside
(25mg + 300mg, 2x1)
Drug: Dexketoprofen Trometamol + Paracetamol
(25mg, 2x1)
Drug: Dexketoprofen Trometamol (25mg)
(500 mg, 4x1)
Drug: Paracetamol
Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg) is a NSAID. It was given to the patients twice a day.
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.
Dexketoprofen Trometamol (25mg) is a NSAID. It was given to the patients twice a day.
Paracetamol (500 mg) is a mild analgesic and antipyretic. It was given to the patients to take only if needed as max. dose 2000mg.
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time frame: 1st week
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time frame: 2nd week
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time frame: 1st month
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time frame: 3rd month
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time frame: 1st week
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time frame: 2nd week
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time frame: 1st month
Trismus Evaluation
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time frame: 3rd month
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time frame: 1st week
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time frame: 2nd week
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time frame: 1st month
Pain Evaluation (at masticatory muscles by palpation)
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Time frame: 3rd month
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time frame: 1st week
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time frame: 2nd week
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time frame: 1st month
Clicking-Crepitus Evaluation
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
Time frame: 3rd month
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Temporomandibular Joint Disorders→
Yuzuncu Yıl University