NCT05802953

Brief Summary

It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

March 26, 2023

Last Update Submit

December 25, 2023

Conditions

Keywords

Temporomandibular Joint Dysfunction SyndromeQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of life scores

    The quality of life will be assess using SF-36. This questionnaire has 8 sections and 36 items. The sections evaluate health between 0-100 and the higher the score indicates the better the quality of life.

    10 minutes

Study Arms (1)

Temporomandibular joint dysfunction group

The group will include patients with temporomandibular joint dysfunction.

Other: Physical assessmentsOther: Questionnaire

Interventions

Physical assessments include the presence of joint sounds (yes/no), Fonseca Anamnestic Questionnaire, tenderness/pressure pain threshold rating, muscle strengths assessments, temporomandibular joint and cervical region range of motion measurements, and pain.

Temporomandibular joint dysfunction group

General Health Questionnaire-28 and SF-36 will be apply.

Temporomandibular joint dysfunction group

Eligibility Criteria

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

Patients will be conducted in Afyonkarahisar Health Science University Faculty of Dentistry. 18-85 aged patients with TMD will be included.

You may qualify if:

  • Being between the ages of 18-65,
  • Being in group I according to RDC/TMD Axis I,

You may not qualify if:

  • Any treatment for temporomandibular joint dysfunction (TMD) in the last six months
  • Having dental problems
  • Having any disorder and/or disease involving structures and/or masticatory muscles associated with TMD
  • Having a history of trauma in the head and neck region,
  • Having previously undergone temporomandibular joint surgery,
  • Using corticosteroid and anticonvulsant drugs
  • Patients who have received physiotherapy and rehabilitation related to the temporomandibular joint in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Taşvuran Horata

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

ErgonomicsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EMEL TAŞVURAN HORATA, PhD

CONTACT

EMEL TAŞVURAN HORATA, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 7, 2023

Study Start

November 2, 2022

Primary Completion

December 25, 2023

Study Completion

December 25, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations