RecruitingNot ApplicableNCT07211711

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

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


Sponsor

University of Sao Paulo General Hospital

Enrollment

63 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

  • 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.

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Interventions

DEVICEStabilizing occlusal splint

Maxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months.

DEVICEplacebo splint

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


Locations(1)

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, São Paulo, Brazil

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NCT07211711


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