Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

The Effects of Occlusal Splint and Exercise in Individuals With 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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorders (TMD)
• Intervention / Treatment: Device: Occlusal Splint; Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helin Yavuz, Physiotherapist; Phone Number: +905312281673; Email: Helin.Yavuz1@live.acibadem.edu.tr
• Study Contact Backup: Name: Sema Savcı, Professor; Email: mailto:sema.savci@acibadem.edu.tr

Study Locations

• Turkey (Türkiye)
  • Tuzla
    • Istanbul, Tuzla, Turkey (Türkiye), 34947
      • Recruiting
      • Okan University- Dental Hospital
      • Contact: Gül Merve Yalçın Ülker, DDS, PhD; Phone Number: +90 533 257 71 70; Email: merve.yalcin@okan.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Splint Group (S Group); S Group will receive nightly occlusal splint therapy only.	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.
Experimental: Exercise and Splint Group (ES Group); ES Group will receive the Rocabado exercise protocol in addition to nightly occlusal splint therapy.	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.; Other Names: Rocabado Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaw Range of Motion	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.	Baseline and 4 weeks after start of treatment
Pain Pressure Threshold	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.	Baseline and 4 weeks after start of treatment
Muscle Mechanical Properties	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).	Baseline and 4 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaw functional limitation scale - 20	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.	Baseline and 4 weeks after start of treatment
Craniofacial Pain and Disability Inventory	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.	Baseline and 4 weeks after start of treatment
Graded chronic pain scale version 2.0	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).	Baseline and 4 weeks after start of treatment

Collaborators and Investigators

• Sponsor: Acibadem University
• Collaborators: Okan University Hospital
• Investigators: Principal Investigator: Helin Yavuz, Physiotherapist, Acibadem University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; exercise therapy; temporomandibular disorders; occlusal splint; muscle mechanical properties; jaw function
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Temporomandibular Joint Disorders; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Orthotic Devices; Exercise; Occlusal Splints
• Other Study ID Numbers: AcibademU/2026-01/56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No