Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Quality of Life and Occlusion Parameters

Conditions
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Occlusion, Quality of Life

Intervention / Treatment
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* Drug: Etodolac 400 MG
* Drug: Thiocolchicoside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No systemic disease that may have effects on masticatory muscles or TMJ Individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed. Exclusion Criteria: Individuals with total or partial prosthesis with distal extension Individuals who have previously received medical, pharmacological or any type of treatment for TMD Individuals who have recently been exposed to facial or cervical trauma Individuals with the syndrome who have the potential to affect any component of the stomatognathic system Individuals with parafunctional habits such as clenching or grinding their teeth.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical therapy<br>One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group. | |
| Active Comparator: Hard Splint Therapy<br>The patients in this group were asked to use a hard splint delivered to them to use at night. | Drug: Etodolac 400 MG<br>* Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.<br>* Other names: Etol Fort;Drug: Thiocolchicoside<br>* Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.<br>* Other names: Muscoflex;|
| Active Comparator: Soft Splint Therapy<br>The patients in this group were asked to use a soft splint delivered to them to use at night. | Drug: Etodolac 400 MG<br>* Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.<br>* Other names: Etol Fort;Drug: Thiocolchicoside<br>* Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.<br>* Other names: Muscoflex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 week- 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T Scan, Facial Myalgia