- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948320
Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study
June 27, 2021 updated by: sevilay seda bas, Ankara Yildirim Beyazıt University
The temporomandibular joint (TMJ), is the only movable joint between the joints in the head and neck system.
It is a component of the chewing system and is involved in important functions such as speech, swallowing, taste and breathing.
Temporomandibular dysfunction (TMD) is the general name given to various musculoskeletal problems seen in the stomatognathic system, mostly affecting the masticatory muscles and/or TMJ.
TMD is the second most common musculoskeletal pain after chronic low back pain.
Patients with TMD may also complain of other musculoskeletal problems, craniocervical problems, sleep problems, and anxiety disorders.
The aim of this study is to investigate, compare and examine the relationship between neck dysfunction, headache and temporomandibular dysfunction severity, anxiety and sleep quality in female individuals.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
212
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Ankara Yildirim Beyazit University
-
-
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
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
temporomandibular disorder and healthy women
Description
Inclusion Criteria:
- Between 18 and 65 years
- Temporomandibular disorders more than 6 months
- Volunteering
Exclusion Criteria:
- Cranio-cervical trauma and temporomandibular operation history
- Infection
- 20-40 points from Fonseca Anamnestic Index 20-40 points
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
Control Group
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Temporomandibular Disorder Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fonseca Anamnestic Index
Time Frame: Baseline
|
Baseline
|
|
Numerical Rating Scale
Time Frame: Baseline
|
Baseline
|
|
Neck Disability Index
Time Frame: Baseline
|
Baseline
|
|
Headache Impact Test
Time Frame: baseline
|
baseline
|
|
General Anxiety Disorder-7 Scale
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 25, 2020
Primary Completion (Actual)
January 25, 2021
Study Completion (Actual)
January 25, 2021
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
June 27, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
July 1, 2021
Last Update Submitted That Met QC Criteria
June 27, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Sleep Wake Disorders
- Anxiety Disorders
- Headache
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- 2020-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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