Clinical trial NCT05261971: Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
Official title: Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Quality of Life and Occlusion Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusion
Quality of Life
Keywords: T Scan
Facial Myalgia
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effects of treatment method on occlusion time parameters
timeFrame: 1 week- 6 month
measure: Effects of treatment method on distribution of right-left occlusion force percentages
timeFrame: 1 week- 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Beyza Ünalan Değirmenci
Study officials:
References:
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citation: Nagata K, Maruyama H, Mizuhashi R, Morita S, Hori S, Yokoe T, Sugawara Y. Efficacy of stabilisation splint therapy combined with non-splint multimodal therapy for treating RDC/TMD axis I patients: a randomised controlled trial. J Oral Rehabil. 2015 Dec;42(12):890-9. doi: 10.1111/joor.12332. Epub 2015 Jul 14.