- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802953
Quality of Life in Temporomandibular Joint Dysfunction
December 25, 2023 updated by: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
Investigation of the Relationship of Individual, Physical and Psychosocial Characteristics With Quality of Life in Temporomandibular Joint Dysfunction
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A recent study showed that individuals with TMD have a lower quality of life than healthy controls.
In addition, it was determined in the study that investigating the quality of life is insufficient.
Future studies should search for psychosocial aspects related to TMD.
The aim of this study is to individual the physical and psychosocial characteristics of individuals with Axis I TMD and examine their relationship with quality of life.
Study Type
Observational
Enrollment (Estimated)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: EMEL TAŞVURAN HORATA, PhD
- Phone Number: 05547759663
- Email: ethorata@gmail.com
Study Contact Backup
- Name: Emel TAŞVURAN HORATA, PhD
- Phone Number: +905547759663
- Email: ethorata@gmail.com
Study Locations
-
-
-
Afyonkarahisar, Turkey, 03030
- Recruiting
- Emel Taşvuran Horata
-
Contact:
- EMEL TAŞVURAN HORATA, PhD
- Phone Number: 05547759663
- Email: ethorata@gmail.com
-
Principal Investigator:
- Emel TAŞVURAN HORATA
-
Sub-Investigator:
- Fatma EKEN
-
Sub-Investigator:
- Olgun TOPAL
-
Sub-Investigator:
- İsmail ÇALIŞKAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Being between the ages of 18-65,
- Being in group I according to RDC/TMD Axis I,
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Temporomandibular joint dysfunction group
The group will include patients with temporomandibular joint dysfunction.
|
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.
General Health Questionnaire-28 and SF-36 will be apply.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life scores
Time Frame: 10 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: EMEL TAŞVURAN HORATA, PhD, Afyonkarahisar Health Sciences University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2022
Primary Completion (Actual)
December 25, 2023
Study Completion (Estimated)
December 25, 2024
Study Registration Dates
First Submitted
March 26, 2023
First Submitted That Met QC Criteria
March 26, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 25, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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