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NCT Number: NCT07211711

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, 05.403-905, Brazil

Location status: Recruiting

Location contact

Gustavo G Machado, Msc

CONTACT

[email protected]

+55 11 26617574

Gustavo G Machado, Msc

SUB_INVESTIGATOR

Jeanne da Rosa Oiticica Ramalho RO Ramalho, PhD

PRINCIPAL_INVESTIGATOR

Matheus Corrêa-Silva, DDs

SUB_INVESTIGATOR

About this study

The clinical variables of somatosensory tinnitus (ZS) will be assessed by a researcher blinded to the treatment type, using the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) at time points T1, T2, T3, T4, and T5, with 30 days interval. The THI, validated and adapted to Portuguese, is the most frequently used questionnaire in clinical trials for tinnitus patients, quantifying the subjective impact of tinnitus on quality of life across three main domains: functional, emotional, and catastrophic. THI classifies tinnitus into five grades: (a) I - negligible (0-16); (b) II - mild (18-36); (c) III - moderate (38-56); (d) IV - severe (58-76); (e) V - catastrophic (78-100). Audiometry and psychoacoustic measures of tinnitus (pitch, loudness, minimum masking level) will be performed at T1 and T5 by an audiologist blind to the treatment group.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

placebo splint

Device

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

Primary outcomes

  1. Changes in somatosensory tinnitus after treatment of temporomandibular joint disorder with a stabilizing occlusal splint.

    Time frame: From enrollment to the end of treatment at 4 months

    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

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

    Time frame: From enrollment to the end of treatment at 4 months

    Tinnitus distress was monitored by a Visual Analog Scale (VAS): Patients rated tinnitus distress on 10-point scale (0 = none; 10 = extreme)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus: a Randomized Double-blind Placebo-controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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