Stabilizing dental splint for TMJ-related somatosensory tinnitus
Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus: a Randomized Double-blind Placebo-controlled Clinical Trial
This will try a stabilizing dental (occlusal) splint to see if it reduces somatosensory tinnitus in adults with temporomandibular joint disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07211711 on ClinicalTrials.gov |
What this trial studies
Adults with somatosensory tinnitus and TMD will receive either a stabilizing occlusal splint or a placebo splint and be followed monthly for about four months. Blinded researchers will measure tinnitus using the Tinnitus Handicap Inventory (THI) and visual analogue scales (VAS) at five timepoints, while an audiologist blinded to group will perform audiometry and psychoacoustic tinnitus measures at baseline and study end. Temporomandibular dysfunction will be assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) and VAS across the same visits. Analyses will look for changes in tinnitus and which patient-, tinnitus-, or TMD-related factors are associated with any treatment effect.
Who should consider this trial
Good fit: Adults (≥18 years) with somatosensory tinnitus and TMD for more than six months, with adequate dentition to the second premolars, Portuguese fluency, and availability for about four months of follow-up.
Not a fit: Patients whose tinnitus is not related to TMD, those recently treated for TMD or tinnitus, users of total/partial removable prostheses, pregnant individuals, or those with other non‑TMD orofacial pain disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the splint could reduce tinnitus severity and improve daily functioning by addressing underlying TMJ dysfunction.
How similar studies have performed: Prior reports show mixed and limited evidence that dental splints can help TMD-related tinnitus, so the approach is plausible but not yet firmly established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old; * Sufferers of somatosensory tinnitus and TMD for more than 6 months; * Dentition in good health, with at least minimal occlusion up to the second premolars on both sides; * Availability for at least 4 months of follow-up; * Able to speak and read the Portuguese language. Exclusion Criteria: Pregnant patients; Treatment for TMD in the last 3 months; Treatment for tinnitus in the last 3 months; Use of total or partial removable prostheses Presence of orofacial pain disorders not related to TMD; Medical contraindication to treatment; Reluctance to accept any designated treatment; Unable or unwilling to give informed consent; Language barrier or delay in neuropsychomotor development.
Where this trial is running
São Paulo, São Paulo
- University of São Paulo Faculty of Medicine Clinics Hospital — São Paulo, São Paulo, Brazil (Recruiting)
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.