About this trial
This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. The main questions we aim to answer are:
* Determine if treatment of temporomandibular disorder with a stabilizing occlusal splint improves somatosensory tinnitus. * Identify which patient-related, tinnitus-related, and temporomandibular disorder-related factors contribute to the therapeutic effect.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Stabilizing occlusal splint
DeviceMaxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months.
placebo splint
DeviceMaxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months.
Treatment groups
Trial outcomes
Primary outcomes
Changes in somatosensory tinnitus after treatment of temporomandibular joint disorder with a stabilizing occlusal splint.
Tinnitus improvement was monitored using the tinnitus handicap inventory (THI). A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100. It subjectively quantifies the impact of tinnitus on the patient's quality of life and classifies tinnitus into 5 degrees: I- negligible (0-16); II- mild (18-36); III- moderate (38-56); IV- severe (58-76); V- catastrophic (78-100).
Secondary outcomes
Somatosensory tinnitus distress reduction after treatment of temporomandibular joint dysfunction with a stabilizing occlusal splint.
Tinnitus distress was monitored by a Visual Analog Scale (VAS): Patients rated tinnitus distress on 10-point scale (0 = none; 10 = extreme)
Sponsors and contacts
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