Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

NCT ID: NCT03209297

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2019-11-05

Brief Summary

TMD treatment, based on state of the art knowledge derived from clinical studies will be applied in patients with tinnitus and TMD. When this approach proves to be useful for the treatment of tinnitus, it offers a new therapeutic option for patients with tinnitus. To understand how TMD treatment works for patients with tinnitus, we will analyse mediating factors, i.e. factors that contribute to the therapeutic effect. To help clinicians in their clinical process we will identify prognostic indicators, i.e. factors that predict a positive or negative outcome of TMD treatment. This can provide a helpful tool in clinical practice.

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Direct treatment

Patients receive the TMD treatment immediately

Group Type: EXPERIMENTAL

TMD treatment: physiotherapy and/or occlusal splints

Intervention Type: OTHER

The patient will receive the most appropriate TMD treatment, based on current literature.

Delayed treatment

No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group

Group Type: EXPERIMENTAL

TMD treatment: physiotherapy and/or occlusal splints

Intervention Type: OTHER

The patient will receive the most appropriate TMD treatment, based on current literature.

Interventions

TMD treatment: physiotherapy and/or occlusal splints

The patient will receive the most appropriate TMD treatment, based on current literature.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients will be included when suffering from somatic tinnitus, attributed to TMD, which has been stable for at least 3 months.
• Tinnitus Functional Index score between 25 and 90

Exclusion Criteria

• clear otological or neurological causes of the tinnitus such as Menière's disease, severe depression (diagnosed by a psychologist), progressive middle ear pathology, intracranial pathology
• traumatic cervical spine or temporomandibular injury in the past 6 months
• tumours
• previous surgery in the orofacial area
• in case physical therapy treatment directed to the orofacial area is contra-indicated
• if the patient received TMD treatment in the past 2 months
• drug intake that can affect the outcome measures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Fonds voor Wetenschappelijk onderzoek Vlaanderen

UNKNOWN

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Sarah Michiels

Post-doctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Countries

Belgium

References

Michiels S, van der Wal AC, Nieste E, Van de Heyning P, Braem M, Visscher C, Topsakal V, Gilles A, Jacquemin L, Hesters M, De Hertogh W. Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial. Trials. 2018 Oct 12;19(1):554. doi: 10.1186/s13063-018-2903-1.

Reference Type: DERIVED

PMID: 30314506 (View on PubMed)

Other Identifiers

T001916N

Identifier Type: -

Identifier Source: org_study_id