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

NCT ID: NCT05261971

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-04-12

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.

Conditions

Occlusion; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical therapy

One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hard Splint Therapy

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

Group Type: ACTIVE_COMPARATOR

Etodolac 400 MG

Intervention Type: DRUG

Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.

Thiocolchicoside

Intervention Type: DRUG

Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.

Soft Splint Therapy

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

Group Type: ACTIVE_COMPARATOR

Etodolac 400 MG

Intervention Type: DRUG

Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.

Thiocolchicoside

Intervention Type: DRUG

Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.

Interventions

Etodolac 400 MG

Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.

Intervention Type: DRUG

Thiocolchicoside

Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.

Intervention Type: DRUG

Other Intervention Names

Etol Fort; Muscoflex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Ünalan Değirmenci

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beyza Ünalan Değirmenci

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 11889659 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 1298767 (View on PubMed)

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 Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

Reference Type: BACKGROUND

PMID: 24482784 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26644756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26174571 (View on PubMed)

Other Identifiers

21.11.2018/01

Identifier Type: -

Identifier Source: org_study_id