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

NCT05261971 | Completed

• 1 other identifier: 21.11.2018/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

T Scan; Facial Myalgia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Medical therapy

NO INTERVENTION

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

Hard Splint Therapy

ACTIVE COMPARATOR

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

Drug: Etodolac 400 MG; Drug: Thiocolchicoside

Soft Splint Therapy

ACTIVE COMPARATOR

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

Drug: Etodolac 400 MG; Drug: Thiocolchicoside

Interventions

Etodolac 400 MG DRUG

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

Also known as: Etol Fort

Hard Splint Therapy; Soft Splint Therapy

Thiocolchicoside DRUG

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

Also known as: Muscoflex

Hard Splint Therapy; Soft Splint Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Beyza Ünalan Değirmenci

Van, 65080, Turkey (Türkiye)

Location

Related 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.

  PMID: 11889659 BACKGROUND

• 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.

  PMID: 1298767 BACKGROUND

• 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.

  PMID: 24482784 BACKGROUND

• 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.

  PMID: 26644756 BACKGROUND

• 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.

  PMID: 26174571 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Interventions

Etodolac; thiocolchicoside

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 2, 2022
• Study Start: December 1, 2018
• Primary Completion: March 24, 2020
• Study Completion: April 12, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: If requested from the principal investigator, information will be shared via e-mail without time limit.
• Access Criteria: If requested from the principal investigator, information will be shared via e-mail without time limit.

Locations

TU (1)