An interventional study of Etodolac 400 MG and Thiocolchicoside in Occlusion and Quality of Life, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Treatment
The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. Today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most frequently used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. However, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. There was no study on the effectiveness of different splints on the patient's quality of life. It would be appropriate to carry out our study to fill this gap in the literature.The main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.
282 studies on the registry are indexed under Myalgia; 43 are open to participants now.
This study's enrollment of 60 is above the median of 44 across 241 interventional studies indexed under Myalgia.
Browse Myalgia 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:
One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group.
The patients in this group were asked to use a hard splint delivered to them to use at night.
Drug: Etodolac 400 MG · Drug: Thiocolchicoside
The patients in this group were asked to use a soft splint delivered to them to use at night.
Drug: Etodolac 400 MG · Drug: Thiocolchicoside
Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.
Also known as: Etol Fort
Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.
Also known as: Muscoflex
Effects of treatment method on occlusion time parameters
Occlusion times, left and right lateral disclusion times and protrusive disclusion times are among the occlusion parameters. In each control session, researchers will record these parameters in seconds using the T-Scan III system.
Time frame: 1 week- 6 month
Effects of treatment method on distribution of right-left occlusion force percentages
In each control session, researchers will record these parameters as percentages using the T-Scan III system.
Time frame: 1 week- 6 month
Plan to share: Yes — If requested from the principal investigator, information will be shared via e-mail without time limit.
Supporting information: Study protocol
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yıl University