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Clinical Trials/NCT05261971
NCT05261971
Completed
Not Applicable

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

Yuzuncu Yıl University1 site in 1 country60 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Etodolac 400 MG
Conditions
Occlusion
Sponsor
Yuzuncu Yıl University
Enrollment
60
Locations
1
Primary Endpoint
Effects of treatment method on occlusion time parameters
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
April 12, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yuzuncu Yıl University
Responsible Party
Principal Investigator
Principal Investigator

Beyza Ünalan Değirmenci

Assistant Professor

Yuzuncu Yıl University

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.

Arms & Interventions

Hard Splint Therapy

The patients in this group were asked to use a hard splint delivered to them to use at night.

Intervention: Etodolac 400 MG

Hard Splint Therapy

The patients in this group were asked to use a hard splint delivered to them to use at night.

Intervention: Thiocolchicoside

Soft Splint Therapy

The patients in this group were asked to use a soft splint delivered to them to use at night.

Intervention: Etodolac 400 MG

Soft Splint Therapy

The patients in this group were asked to use a soft splint delivered to them to use at night.

Intervention: Thiocolchicoside

Outcomes

Primary Outcomes

Effects of treatment method on occlusion time parameters

Time Frame: 1 week- 6 month

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.

Effects of treatment method on distribution of right-left occlusion force percentages

Time Frame: 1 week- 6 month

In each control session, researchers will record these parameters as percentages using the T-Scan III system.

Study Sites (1)

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