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Temporomandibular Dysfunction in Patients With Tinnitus: Assessment and Treatment

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ClinicalTrials.gov Identifier: NCT03209297
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
University Hospital, Antwerp
Fonds voor Wetenschappelijk onderzoek Vlaanderen
Information provided by (Responsible Party):
Sarah Michiels, Universiteit Antwerpen

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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Other: TMD treatment: physiotherapy and/or occlusal splints Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One study arm will be treated immediately after inclusion. The other study arm will be treated after a delay of 9 weeks. During these 9 weeks patients will be on a waiting list.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Conservative Treatment of Temporomandibular Disorders on Somatic Tinnitus
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Direct treatment
Patients receive the TMD treatment immediately
Other: TMD treatment: physiotherapy and/or occlusal splints
The patient will receive the most appropriate TMD treatment, based on current literature.

Experimental: Delayed treatment
No intervention in the first 9 weeks of the study. Afterwards, the patients receive the same treatment as the other group
Other: TMD treatment: physiotherapy and/or occlusal splints
The patient will receive the most appropriate TMD treatment, based on current literature.




Primary Outcome Measures :
  1. Tinnitus Questionnaire [ Time Frame: Baseline, 9 weeks, 18 weeks, 27 weeks ]
    Questionnaire to measure the change in tinnitus related distress


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209297


Contacts
Contact: Paul Van de Heyning, PhD, MD +32 3 821 33 85 paul.vandeheyning@uza.be
Contact: Willem De Hertogh, PhD willem.dehertogh@uantwerpen.be

Locations
Belgium
Universitair ziekenhuis Antwerpen Recruiting
Edegem, Antwerpen, Belgium
Contact: Sarah Michiels, PhD       sarah.michiels@uantwerpen.be   
Contact: Evelien Nieste, MSc.       evelien.nieste@uantwerpen.be   
Sponsors and Collaborators
Universiteit Antwerpen
University Hospital, Antwerp
Fonds voor Wetenschappelijk onderzoek Vlaanderen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Michiels, Post-doctoral researcher, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03209297     History of Changes
Other Study ID Numbers: T001916N
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms