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NCT Number: NCT07507734

Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Okan University- Dental Hospital

Istanbul, Tuzla, 34947, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gül Merve Yalçın Ülker, DDS, PhD

CONTACT

[email protected]

+90 533 257 71 70

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occlusal splint

Device

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.

Exercise

Behavioral

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.

Other names: Rocabado Exercises

Primary outcomes

  1. Jaw Range of Motion

    Time frame: Baseline and 4 weeks after start of treatment

    Pain-free opening, maximum unassisted opening, maximum assisted opening, lateral and protrusive movements will be mesured by a ruler. All measurements will be noted in milimeters between the incisal edges of upper and lower central incisors. The average of the 3 repetitions will be taken.

  2. Pain Pressure Threshold

    Time frame: Baseline and 4 weeks after start of treatment

    PPT will be evaluated using a digital algometer. After positioning the algometer's rubbet tip pressure will be applied gradually. Measurements will be taken from the belly of the muscles (bilaterally for the masseter, temporalis, sternocleidomastoid and trapezius). The measurements will be made in three repetitions and the average will be noted in kg/cm2.

  3. Muscle Mechanical Properties

    Time frame: Baseline and 4 weeks after start of treatment

    Muscle mechanical properties will be evaluated by the MyotonPRO (Myoton AS, Tallinn, Estonia) device. Device will perform 5 measurements by 15-seconds intervals and the mean values will be recorded. Measurements will be taken from the belly of the muscles (bilaterally masseter, temporalis, sternocleidomastoid and trapezius).

Secondary outcomes

  1. Jaw functional limitation scale - 20

    Time frame: Baseline and 4 weeks after start of treatment

    JLFS-20 will be used to evaluate functional limitations of the jaw. It consists of 20-items and each item scored between 0 (no limitation) to 10 (severe limitaiton) score.

  2. Craniofacial Pain and Disability Inventory

    Time frame: Baseline and 4 weeks after start of treatment

    Craniofacial pain and disability inventory will be used to evaluate TMD-related pain, neck pain, headache and ear pain. It consist of 21 items and each scored on a 4-point Likert-scale ranging from 0 ('no problem') to 3 ('maximum problem') score.

  3. Graded chronic pain scale version 2.0

    Time frame: Baseline and 4 weeks after start of treatment

    Graded chronic pain scale version 2.0 will be used to evaluate pain intensity and pain-related disability over the last 30 days. Chronic pain is graded from grade 1 (indicating low intensity pain-low disability) to grade 4 (indicating high disability-severly limiting).

Study contacts

Contact information is provided by the study sponsor or research team.

Helin Yavuz, Physiotherapist

CONTACT

[email protected]

+905312281673

Sema Savcı, Professor

CONTACT

mailto:[email protected]

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Collaborators

  • Okan University Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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