- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06937333
Pain and Mobility in Children With Sleep Bruxism
April 17, 2025 updated by: METEHAN YANA, Karabuk University
Investigation of Pain, Cervical Joint Range of Motion, and Sleep Quality in Children With Bruxism
Bruxism is defined as a repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement.
Sleep bruxism is frequently seen and can affect the quality of life of individuals.
Since bruxism is characterized by clenching teeth, it can cause pain.
However, the relationship between bruxism and pain has not been sufficiently studied in the literature.
The relationship between the temporamandibular joint and the cervical region is known.
However, the relationship between bruxism and cervical mobility is not clear.
Since there may be temporamandibular joint problems in bruxism, it can affect joint movement.
The sleep quality of individuals may decrease and this may lead to problems in functionality.
However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained.
Therefore, the aim of the study was to compare the pain, range of motion, sleep quality and functional independence of children with bruxism and healthy controls.
Study Overview
Status
Completed
Conditions
Detailed Description
Bruxism is defined as repetitive jaw muscle activity characterized by clenching and grinding teeth caused by mandibular movement.
Sleep bruxism is frequently seen and can affect the quality of life of individuals.
Since bruxism is characterized by clenching teeth, it can cause pain.
However, the relationship between bruxism and pain has not been sufficiently studied in the literature.
In addition, bruxism can cause problems in joint mobility of the cervical region by affecting the activation of muscles.
Although the relationship between the temporomandibular joint and the cervical region is clearly known, the relationship between bruxism and cervical mobility is not clear.
For this reason, sleep problems are frequently seen in individuals.
The sleep quality of individuals decreases and can cause problems in functionality.
However, when the literature is examined, the relationship between bruxism and functional independence in children has not been explained.
Since bruxism can reduce the quality of life of individuals due to the indirect effects it causes, it should be seen and evaluated not only as a disorder involving the jaw joint, but as a problem affecting the entire body.
Therefore, the aim of the study was to compare pain, range of motion, sleep quality and functional independence in children with bruxism and healthy controls.
Study Type
Observational
Enrollment (Actual)
80
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
-
-
-
Karabük, Turkey, 78000
- Karabuk 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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Children with bruxism and healthy controls
Description
Inclusion Criteria:
- Having been diagnosed with Nocturnal Bruxism
- Having received parental consent to participate in the study
- Being between the ages of 13-18
- Being in good mental condition
- Being able to understand and follow the instructions in the study
- Having Class 1 occlusion
Exclusion Criteria:
- Not consenting to participate in the study or withdrawing from the study
- Not being able to cooperate well
- Having a history of surgery
- Having any physical disability or chronic disease
- Having received dental treatment in the last 6 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 |
|---|
|
Sleep bruxism
Children diagnosed with sleep bruxism were included in this study.
|
|
Control Group
Age- and sex-matched healthy children were included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold
Time Frame: Baseline
|
Pain pressure threshold was evaluated the algometer.
|
Baseline
|
|
Range of motion
Time Frame: Baseline
|
Cervical range of motion was evaluated with the cervical range of motion device (CROM) developed by the University of Minnesota, USA,
|
Baseline
|
|
Functional Independence
Time Frame: Baseline
|
Functional Independence was evaluated the with the Pediatric Functional Independence Measure.
The total score varies between 18-126 and as the score increases, the dependency increases.
|
Baseline
|
|
Sleep quality
Time Frame: Baseline
|
Sleep quality was evaluated the Pitsburg Sleep Quality Index.
The total score ranges from 0 to 21, and as the score increases, sleep quality decreases.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Metehan Yana, PhD, Karabuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
June 15, 2024
Primary Completion (Actual)
February 15, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
April 10, 2025
First Submitted That Met QC Criteria
April 17, 2025
First Posted (Actual)
April 22, 2025
Study Record Updates
Last Update Posted (Actual)
April 22, 2025
Last Update Submitted That Met QC Criteria
April 17, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk-007
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.
Clinical Trials on Bruxism, Sleep
-
Melek Volkan YaziciCompletedBruxism | Bruxism, Sleep-Related | Bruxism, SleepTurkey (Türkiye)
-
Baskent UniversityRecruiting
-
University of MonastirCompletedBruxism | Bruxism, Sleep-RelatedTunisia
-
Nigde Omer Halisdemir UniversityRecruitingBruxism | Bruxism, Sleep-RelatedTurkey (Türkiye)
-
Cappadocia UniversityCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Wroclaw Medical UniversityNot yet recruitingBruxism, Sleep-Related | Sleep Apnea Syndrome, Obstructive | Upper Respiratory Tract IllnessPoland
-
Escoles Universitaries GimbernatUniversitat Internacional de CatalunyaNot yet recruitingBruxism, SleepSpain
-
Ankara Yildirim Beyazıt UniversityCompleted
-
University of California, San FranciscoWithdrawn