NCT04434859

Brief Summary

The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 10, 2020

Last Update Submit

June 14, 2020

Conditions

TinnitusTemporomandibular Disorder

Outcome Measures

Primary Outcomes (2)

  • Description of temporomandibular disorders in the patient's history

    A questioannaire asking specifically about pain in the tempromandibular joint, headaches, clicks, tempromandibular joint locking and dislocation

    1 year

  • Positive findings in the physical examination of the temporomandibular joint and muscles

    The following parameters will be documented: clicks, maximal opening of the mouth, signs of teeth grinding, tenderness on the mastication muscles

    1 year

Study Arms (1)

Patients with tinnitus

Patients (over 18 years old) seen at the medical center due to tinnitus, lasting at least 3 months.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Patients with tinnitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with tinnitus lasting more than 3 months

You may qualify if:

  • Tinnitus lasting more than 3 months

You may not qualify if:

  • Head and Neck Space Occupying Lesion
  • Previous degenerative disease of the temporomandibular koint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TinnitusTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 17, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share