Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus

NCT07211711 | Recruiting

• 1 other identifier: 67418823.4.0000.0068
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus; TMJ; Temporomandibular Disorders (TMD)

Keywords

tinnitus; temporomandibular disorders; TMD; temporomandibular joint; TMJ; bite splint; occlusal splint; splint; stabilizing splint; somatosensory tinnitus

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of treatment at 4 months

Secondary Outcomes (1)

• Somatosensory tinnitus distress reduction after treatment of temporomandibular joint dysfunction with a stabilizing occlusal splint.

  From enrollment to the end of treatment at 4 months

Study Arms (2)

Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splint

ACTIVE COMPARATOR

They will undergo the use of a stabilizing occlusal splint and will be followed up for 4 months.

Device: Stabilizing occlusal splint

Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint

PLACEBO COMPARATOR

They will undergo the use of a placebo splint and will be followed up for 4 months.

Device: placebo splint

Interventions

Stabilizing occlusal splint DEVICE

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 occlusal splint

placebo splint DEVICE

Maxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months.

Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, São Paulo, 05.403-905, Brazil

RECRUITING

MeSH Terms

Conditions

Tinnitus; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 8, 2025
• Study Start: August 10, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

BR (1)