Occlusal Splint and Exercise Therapy for Temporomandibular Disorders

NCT07507734 | Recruiting

• 1 other identifier: AcibademU/2026-01/56
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

temporomandibular disorders; exercise therapy; occlusal splint; muscle mechanical properties; pain; jaw function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Jaw functional limitation scale - 20

  Baseline and 4 weeks after start of treatment

• Craniofacial Pain and Disability Inventory

  Baseline and 4 weeks after start of treatment

• Graded chronic pain scale version 2.0

  Baseline and 4 weeks after start of treatment

Study Arms (2)

Splint Group (S Group)

ACTIVE COMPARATOR

S Group will receive nightly occlusal splint therapy only.

Device: Occlusal Splint

Exercise and Splint Group (ES Group)

EXPERIMENTAL

ES Group will receive the Rocabado exercise protocol in addition to nightly occlusal splint therapy.

Device: Occlusal Splint; Behavioral: Exercise

Interventions

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 and Splint Group (ES Group); Splint Group (S Group)

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.

Also known as: Rocabado Exercises

Exercise and Splint Group (ES Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead
• Okan University Hospital: collaborator

Study Sites (1)

Okan University- Dental Hospital

Istanbul, Tuzla, 34947, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 24482784 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Occlusal Splints; Exercise

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helin Yavuz, Physiotherapist

  Acibadem University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helin Yavuz, Physiotherapist

CONTACT

+905312281673; Helin.Yavuz1@live.acibadem.edu.tr

Sema Savcı, Professor

CONTACT

mailto:sema.savci@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc Student

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TU (1)