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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261971
• Other study ID #: 21.11.2018/01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 12, 2020

Study information

• Verified date: February 2022
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 12, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myalgia
• Occlusion
• Quality of Life

Intervention

Drug:
• Etodolac 400 MG
Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.
• Thiocolchicoside
Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.

Locations

Country	Name	City	State
Turkey	Beyza Ünalan Degirmenci	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Dworkin SF, Huggins KH, Wilson L, Mancl L, Turner J, Massoth D, LeResche L, Truelove E. A randomized clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to target clinic cases for a tailored self-care TMD treatment program. J Orofac Pain. 2002 Winter;16(1):48-63. — View Citation

Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. Review. — View 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. — View Citation

Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation

Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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