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OpenTrials
Completed

NCT Number: NCT03209297

Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

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.

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TMD treatment: physiotherapy and/or occlusal splints

Other

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

Primary outcomes

  1. Tinnitus Questionnaire

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    Questionnaire to measure the change in tinnitus related distress

Secondary outcomes

  1. Tinnitus Functional Index

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    Questionnaire to measure the change in tinnitus severity

  2. Hyperacusis Questionnaire

    Time frame: Baseline

    Questionnaire to measure the presence of hyperacusis

  3. Visual analogue scale for tinnitus loudness

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    Scale to measure the change in average tinnitus loudness

  4. TMD pain screener

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    Questionnaire to assess the presence of and change in temporomandibular disorders(TMD) symptoms

  5. Hospital anxiety and depression scale

    Time frame: Baseline

    Questionnaire to measure the presence of anxiety and/or depression

  6. Specific anamnestic questions

    Time frame: Baseline

    pre-defined list of questions on duration of the tinnitus complaints, modulation, bruxism,...

  7. Static investigation of the temporomandibular joint

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    evaluation of change in isometric contraction of jaw muscles

  8. Dynamic investigation of the temporomandibular joint

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    evaluation of change in isotonic contraction of jaw muscles

  9. Pain pressure threshold

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    measurement of change in pain pressure thresholds on masseter, temporalis, temporomandibular joint, sternocleidomastoideus, tibialis anterior

  10. Mouth opening

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    change in mouth opening measured in cm with a ruler

  11. Pain on palpation of masseter, temporalis and temporomandibular joint

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    change in recognisable pain on palpation, measured on numerical rating scale

  12. Tinnitus Analysis

    Time frame: Baseline

    analysis of the tinnitus type, pitch and loudness

  13. Speech in noise test

    Time frame: Baseline, 9 weeks, 18 weeks, 27 weeks

    analysis of the change in understanding spoken words in a noisy situation

  14. Pure tone audiometry

    Time frame: Baseline

    evaluation of possible hearing problems

  15. Auditory evoked potentials measurement

    Time frame: Baseline, 18 weeks

    change in EEG during listening tasks

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Fonds voor Wetenschappelijk onderzoek Vlaanderen
  • University Hospital, Antwerp

Registry information

Official study title

The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2017
Registry last updated
Nov 6, 2019

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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