Actively Recruiting
Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus: a Randomized Double-blind Placebo-controlled Clinical Trial
Led by University of Sao Paulo General Hospital · Updated on 2025-10-08
63
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether treating temporomandibular joint disorder (TMD) with a stabilizing occlusal splint can help reduce somatosensory tinnitus. This trial also aims to identify which patient, tinnitus, and TMD factors may influence the treatment's effect. The study is a randomized, double-blind, placebo-controlled clinical trial designed to provide clear evidence about this treatment approach. Participants are assigned to one of two groups: one uses a maxillary stabilizing occlusal splint made of acrylic with a 2mm thickness in the back, while the other uses a placebo non-occlusal splint. Both splints are installed and evaluated monthly over a four-month period. The study involves monthly follow-ups during this time to monitor progress and treatment effects. Throughout the study, participants undergo assessments at five time points spaced 30 days apart. These include the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) to measure tinnitus impact and distress, as well as clinical evaluations of TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Audiometry and psychoacoustic tinnitus measures are performed at the start and end of treatment. Researchers monitor changes in tinnitus after treatment and assess safety and adherence during the four-month follow-up.
CONDITIONS
Brief Title
Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Sufferers of somatosensory tinnitus and temporomandibular joint disorder for more than 6 months
- Dentition in good health, with at least minimal occlusion up to the second premolars on both sides
- Available for at least 4 months of follow-up
- Able to speak and read the Portuguese language
You will not qualify if you...
- Pregnant patients
- Treatment for temporomandibular joint disorder 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 temporomandibular joint disorder
- Medical contraindication to treatment
- Reluctance to accept any designated treatment
- Unable or unwilling to give informed consent
- Language barrier or delay in neuropsychomotor development
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive a maxillary stabilizing occlusal splint or a placebo splint installed and evaluated monthly to treat temporomandibular joint disorder and somatosensory tinnitus.
Monthly visits for 4 months
Duration - 4 months
Participants are assessed for changes in tinnitus and temporomandibular joint disorder symptoms using questionnaires and audiometric tests at multiple time points.
5 visits at 30-day intervals
Trial Site Locations
Total: 1 location
1
University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, São Paulo, Brazil, 05.403-905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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