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Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

NCT07507734 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Temporomandibular Disorders (TMD)

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 performing 6 specific exercises, 6 times per day with 6 repetitions each, for 4 weeks.

Sponsors & Collaborators

  • Okan University Hospital

    collaborator UNKNOWN

  • Acibadem University

    lead OTHER

Principal Investigators

  • Helin Yavuz, Physiotherapist · Acibadem University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-07-10
Completion
2026-07-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507734 on ClinicalTrials.gov