NCT05402228

Brief Summary

120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria. maximum mouth opening, TMJ sound, pain levels, tinnitus, and dizziness are evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

March 27, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

May 28, 2022

Last Update Submit

July 11, 2022

Conditions

Keywords

temporomandibular jointdizzinessaural sypmtomstinnitus

Outcome Measures

Primary Outcomes (4)

  • maximum mouth opening

    maximum mouth opening

    1 day

  • right and left lateral movement, deflexion, and deviation

    right and left lateral movement, deflexion, and deviation

    1 day

  • TMJ sound

    the TMJis palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh was noted.

    1 day

  • visual analog scale

    It is use for evaluate the pain intensity.

    1 day

Secondary Outcomes (2)

  • bruxism

    1 day

  • the presence of bruxism, tinnitus and dizzeness

    1 day

Interventions

no intervention

Eligibility Criteria

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

participants aged 18-65 years with TMD

You may qualify if:

  • being 18-65 years of age
  • diagnosed with TMD

You may not qualify if:

  • Lack of cognitive ability to understand test instructions, illliteracy, aphasia, presence of a known psychiatric illness
  • Patients under the age of 18 and over the age of 65
  • Having another systemic disease that will cause TMD (cancer, rheumatological diseases)
  • Presence of disease that will increase a anotherural symptoms or cause d d (presence of disease of vertigo, history of vertigo)
  • Presence of a history of cervical pain, cervical spondylosis, cervical disc herniation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersDizzinessTinnitus

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 28, 2022

First Posted

June 2, 2022

Study Start

March 27, 2022

Primary Completion

June 1, 2022

Study Completion

June 15, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations