Occlusal splint plus Rocabado jaw exercises for temporomandibular disorder
The Effects of Occlusal Splint and Exercise in Individuals With Temporomandibular Disorders
This project will see if adding daily Rocabado jaw exercises to nightly occlusal splint use helps adults (18-65) with temporomandibular disorder reduce pain, improve jaw movement, and change muscle mechanical properties.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Acibadem University Academic / other |
| Locations | 1 site (Istanbul, Tuzla) |
| Trial ID | NCT07507734 on ClinicalTrials.gov |
What this trial studies
This is a two-arm, randomized, controlled prospective trial comparing nightly occlusal splint therapy alone to occlusal splint therapy combined with the Rocabado 6x6 exercise protocol in adults with TMD. Participants will be stratified by age, gender, and occupation and will undergo baseline and 4-week follow-up assessments. Measured outcomes include patient-reported pain and function (JLFS-20, CF-PDI, GCPS-2.0), jaw range of motion, pain pressure thresholds, and objective muscle mechanical properties of the masticatory and neck muscles. The exercise-plus-splint group will perform six daily sessions of six Rocabado exercises while both groups use a nightly occlusal splint for four weeks.
Who should consider this trial
Good fit: Adults aged 18-65 with a clinical and radiological diagnosis of TMD and at least three months of TMJ pain who can attend clinic visits in Istanbul and perform the daily exercise regimen are ideal candidates.
Not a fit: Patients with intra-articular degenerative joint disease, recent TMJ or cervical surgery, rheumatic disease, TMJ instability or fracture, cognitive impairment, or chronic neuropathic facial pain are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined approach could provide a simple, low-cost way for patients to reduce TMD pain and improve jaw function more effectively than splint therapy alone.
How similar studies have performed: Previous studies show occlusal splints and targeted exercise programs can each improve TMD symptoms, but randomized comparisons of the combined splint-plus-exercise approach versus splint alone, particularly including muscle mechanical property outcomes, are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul, Tuzla
- Okan University- Dental Hospital — Istanbul, Tuzla, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Helin Yavuz, Physiotherapist — Acibadem University
- Study coordinator: Helin Yavuz, Physiotherapist
- Email: Helin.Yavuz1@live.acibadem.edu.tr
- Phone: +905312281673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.