Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus
NCT ID: NCT07211711
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
63 participants
INTERVENTIONAL
2023-08-10
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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The clinical variables of temporomandibular dysfunction (TMD) will also be assessed by a researcher blinded to the treatment type, using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) and VAS at the same time points. The DC/TMD is a validated tool, adapted to Portuguese, used in clinical trials that provides a systematic assessment, including a standardized clinical examination and questionnaires. This classification system, based on the biopsychosocial model of pain, includes a physical assessment through Axis I, using reliable and well-operationalized diagnostic criteria, and an assessment of the psychosocial status and pain-related disability through Axis II.
Both assessments will be conducted at T1, T2, T3, T4, and T5.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splint
They will undergo the use of a stabilizing occlusal splint and will be followed up for 4 months.
Stabilizing occlusal splint
Maxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months.
Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint
They will undergo the use of a placebo splint and will be followed up for 4 months.
placebo splint
Maxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months.
Interventions
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Stabilizing occlusal splint
Maxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months.
placebo splint
Maxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Jeanne Oiticica
PhD
Locations
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University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, São Paulo, Brazil
Countries
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Facility Contacts
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Other Identifiers
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67418823.4.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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