Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

Official title

The Effects of Occlusal Splint and Exercise in Individuals With Temporomandibular Disorders

Overview

The goal of this clinical trial is to learn if an exercise protocol can improve temporomandibular pain, jaw function and muscle mechanical properties in individuals with Temporomandibular Disorders (TMD). This study focuses on patients who are already receiving occlusal splint therapy. The main question it aims to answer is: How does the addition of an exercise protocol to occlusal splint therapy affect temporomandibular pain, jaw function and muscle mechanical properties of the masticatory and neck muscles? Researchers will compare the group receiving both occlusal splint therapy and the exercise protocol to a group only occlusal splint therapy to see if the combined approach is more effective. Participants will: * Undergo an initial assessment of the Jaw Functional Limitation Scale-20 (JLFS-20), Craniofacial Pain and Disability Inventory (CF-PDI), Graded Chronic Pain Scale Version 2.0 (GCPS-2.0), jaw range of motion, pain pressure threshold and muscle mechanical properties. * Receive occlusal splint therapy as a part of their treatment. * Perform a structured exercise protocol (only 1 group) * Attend follow up sessions at the 4th week to monitor changes in all initial assessment parameters.

Detailed description

This research will be conducted as a randomized controlled, two-arm, prospective clinical trial. The study will evaluate the effects of occlusal splint application combined with the Rocabado exercise protocol in individuals with TMD. The intervention period will last for 4 weeks, with assessments conducted at baseline and at the end of the 4 weeks period.

Literature indicates that occlusal splint therapy and specialized exercise protocols are beneficial in improving symptoms in individuals with temporomandibular disorders (TMD). Studies have demonstrated that these interventions can enhance functionality and alleviate pain. However, there is a lack of research specifically comparing the combination of an occlusal splint and an exercise protocol against splint therapy alone, particularly regarding their effects on pain, functionality, and the mechanical properties of the masticatory and neck muscles.

Participants diagnosed with TMD will be recruited from two clinics in Turkey. To prevent potential imbalances, participants will be divided into two groups using stratification (age, gender, and occupation) and block randomization:

* Splint Group (S Group): Will receive nightly occlusal splint therapy only. * Exercise and Splint Group (ES Group): Will receive the Rocabado 6x6 exercise protocol in addition to nightly occlusal splint therapy.

In the ES group, the occlusal splint and Rocabado exercises (6 times daily, 6 repetitions each) will be performed 7 days a week for 4 weeks. The control (S) group will utilize only the occlusal splint for the same duration.

Evaluations will be performed at baseline and at the 4th week. Clinical assessments will include the Jaw Functional Limitation Scale-20 (JFLS-20), Craniofacial Pain and Disability Inventory (CF-PDI), and Graded Chronic Pain Scale (GCPS) 2.0. Additionally, temporomandibular joint range of motion (ROM), pressure pain threshold (PPT), and mechanical muscle properties (MyotonPRO) will be assessed.

Inclusion criteria

* Clinical and radiological diagnosis of TMD * Being between 18-65 years of age, * Presence of temporomansibular joint (TMJ) pain for the last 3 months. Exclusion criteria * İntra-articular or degenerative joint disorders and subluxation requiring immediate treatment, * A history of TMJ or cervical region surgery in the last 3 months, * A history of treatment from related regions, * The presence of rheumatic diseases, including TMJ diseases, * TMJ instability or fracture, * The presence of perception-cognition disorder, * The presence of chronic pain, such as trigeminal neuralgia.

Interventions

• Device Occlusal Splint
  Participants will be provided with custom-made hard acrylic occlusal splints. They will be instructed to wear the appliance every night during sleep for a period of four consecutive weeks. A licensed dentist will manage the delivery and occlusal adjustment of the splints to ensure they were correctly seated and well-tolerated by the subjects. Both groups will receive a occlusal splint to be worn every night.
• Behavioral Exercise
  Participants will perform the Rocabado 6x6 exercise protocol, which consists of six specific movements designed to restore proper tongue position, improve jaw mobility, and stabilize the craniomandibular relationship. Each exercise will be performed 6 times per session, 6 times a day. The protocol includes: Rest position of the tongue, shoulder posture, stabilized head flexion, axial extension of the neck, control of TMJ rotation and rhythmic stabilization technique. The program consists of perf

Primary outcome measures

• Jaw Range of Motion [Time frame: Baseline and 4 weeks after start of treatment]
• Pain Pressure Threshold [Time frame: Baseline and 4 weeks after start of treatment]
• Muscle Mechanical Properties [Time frame: Baseline and 4 weeks after start of treatment]

Secondary outcome measures (3)

• Jaw functional limitation scale - 20 [Time frame: Baseline and 4 weeks after start of treatment]
• Craniofacial Pain and Disability Inventory [Time frame: Baseline and 4 weeks after start of treatment]
• Graded chronic pain scale version 2.0 [Time frame: Baseline and 4 weeks after start of treatment]

Eligibility criteria

Inclusion criteria

• Clinical and radiological diagnosis of TMD
• Being between 18-65 years of age
• Presence of Temporomandibular Joint (TMJ) pain for the last 3 months.

Exclusion criteria

• Intra-articular or degenerative joint disorders and subluxation requiring immediate treatment,
• A history of TMJ or cervical region surgery in the last 3 months,
• A history of treatment from related regions,
• The presence of rheumatic diseases, including TMJ diseases,
• TMJ instability or fracture,
• The presence of perception-cognition disorder,
• The presence of chronic pain, such as trigeminal neuralgia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Okan University- Dental Hospital — Istanbul

Publications

• Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27. PMID 20524969
• Shimada A, Ishigaki S, Matsuka Y, Komiyama O, Torisu T, Oono Y, Sato H, Naganawa T, Mine A, Yamazaki Y, Okura K, Sakuma Y, Sasaki K. Effects of exercise therapy on painful temporomandibular disorders. J Oral Rehabil. 2019 May;46(5):475-481. doi: 10.1111/joor.12770. Epub 2019 Feb 19. PMID 30664815
• 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 PMID 24482784
• Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28. PMID 18018993
• Idanez-Robles AM, Obrero-Gaitan E, Lomas-Vega R, Osuna-Perez MC, Cortes-Perez I, Zagalaz-Anula N. Exercise therapy improves pain and mouth opening in temporomandibular disorders: A systematic review with meta-analysis. Clin Rehabil. 2023 Apr;37(4):443-461. doi: 10.1177/02692155221133523. Epub 2022 Oct 20. PMID 36263523

Identifiers

NCT: NCT07507734 · AcibademU/2026-01/56

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗