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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splintActive comparator 1 intervention
Group B: Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splintPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
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.

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

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

Other outcomes

Sponsors and contacts

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