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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Occlusion
• Intervention / Treatment: Drug: Etodolac 400 MG; Drug: Thiocolchicoside

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Beyza Ünalan Değirmenci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: Hard Splint Therapy; The patients in this group were asked to use a hard splint delivered to them to use at night.	Drug: Etodolac 400 MG; Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.; Other Names: Etol Fort; Drug: Thiocolchicoside; Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.; Other Names: Muscoflex
Active Comparator: Soft Splint Therapy; The patients in this group were asked to use a soft splint delivered to them to use at night.	Drug: Etodolac 400 MG; Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.; Other Names: Etol Fort; Drug: Thiocolchicoside; Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.; Other Names: Muscoflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): April 12, 2020

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: T Scan; Facial Myalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etodolac
• Other Study ID Numbers: 21.11.2018/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: If requested from the principal investigator, information will be shared via e-mail without time limit.
• IPD Sharing Time Frame: If requested from the principal investigator, information will be shared via e-mail without time limit.
• IPD Sharing Access Criteria: If requested from the principal investigator, information will be shared via e-mail without time limit.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No