Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

Tinnitus, Subjective Clinical Trial

Official title:

The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209297
• Other study ID #: T001916N
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: November 5, 2019

Study information

• Verified date: November 2019
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 5, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• TMD treatment: physiotherapy and/or occlusal splints
The patient will receive the most appropriate TMD treatment, based on current literature.

Locations

Country	Name	City	State
Belgium	Universitair ziekenhuis Antwerpen	Edegem	Antwerpen

Sponsors (3)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Fonds voor Wetenschappelijk onderzoek Vlaanderen, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Questionnaire	Questionnaire to measure the change in tinnitus related distress	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Tinnitus Functional Index	Questionnaire to measure the change in tinnitus severity	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Hyperacusis Questionnaire	Questionnaire to measure the presence of hyperacusis	Baseline
Secondary	Visual analogue scale for tinnitus loudness	Scale to measure the change in average tinnitus loudness	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	TMD pain screener	Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Hospital anxiety and depression scale	Questionnaire to measure the presence of anxiety and/or depression	Baseline
Secondary	Specific anamnestic questions	pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...	Baseline
Secondary	Static investigation of the temporomandibular joint	evaluation of change in isometric contraction of jaw muscles	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Dynamic investigation of the temporomandibular joint	evaluation of change in isotonic contraction of jaw muscles	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Pain pressure threshold	measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Mouth opening	change in mouth opening measured in cm with a ruler	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Pain on palpation of masseter, temporalis and temporomandibular joint	change in recognisable pain on palpation, measured on numerical rating scale	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Tinnitus Analysis	analysis of the tinnitus type, pitch and loudness	Baseline
Secondary	Speech in noise test	analysis of the change in understanding spoken words in a noisy situation	Baseline, 9 weeks, 18 weeks, 27 weeks
Secondary	Pure tone audiometry	evaluation of possible hearing problems	Baseline
Secondary	Auditory evoked potentials measurement	change in EEG during listening tasks	Baseline, 18 weeks