Bruxism, SleepNCT06937333
Pain and Mobility in Children With Sleep Bruxism
An observational study of Bruxism, Sleep, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Sleep
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with bruxism and healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bruxism, Sleep
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep bruxism | Children diagnosed with sleep bruxism were included in this study. | |
| Control Group | Age- and sex-matched healthy children were included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Pain pressure threshold was evaluated the algometer.
Measured: Baseline
Range of motion
Cervical range of motion was evaluated with the cervical range of motion device (CROM) developed by the University of Minnesota, USA,
Measured: Baseline
Functional Independence
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.
Measured: Baseline
Sleep quality
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start15 Jun 2024
- Primary completion15 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bruxism, SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
- Investigators
- Metehan Yana, PhD, Study director, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937333
- Sponsor's protocol ID
- Karabuk-007
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brancher LC, Cademartori MG, Jansen K, da Silva RA, Bach S, Reyes A, Boscato N, Goettems ML. Social, emotional, and behavioral problems and parent-reported sleep bruxism in schoolchildren. J Am Dent Assoc. 2020 May;151(5):327-333. doi: 10.1016/j.adaj.2020.01.025. Epub 2020 Mar 26.
PubMed 32223910
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain, Cervical Joint Range of Motion, and Sleep Quality in Children With Bruxism
- ClinicalTrials.gov ID
- NCT06937333
- Acronym / sponsor ID
- Karabuk-007
- Conditions
- Bruxism, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep bruxism | – | –Children diagnosed with sleep bruxism were included in this study. |
| Control Group | – | –Age- and sex-matched healthy children were included. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with bruxism and healthy controls
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain pressure threshold
Time frame: Baseline
Pain pressure threshold was evaluated the algometer.
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,
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Results publication: PubMed 32223910Brancher LC, Cademartori MG, Jansen K, da Silva RA, Bach S, Reyes A, Boscato N, Goettems ML. Social, emotional, and behavioral problems and parent-reported sleep bruxism in schoolchildren. J Am Dent Assoc. 2020 May;151(5):327-333. doi: 10.1016/j.adaj.2020.01.025. Epub 2020 Mar 26.
- Individual participant dataSharing planned: No
Related trials for Bruxism, Sleep
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
Not yet recruitingObservational study
Bruxism Induced by Obstructive Sleep Apnoea.
Sleep Apnea Syndrome, Obstructive, Bruxism, Sleep-Related
Enrolling by invitationObservational study
Relationship Between Selected Parameters and Bruxism
Sleep Bruxism, Sleep Disorder
Active, not recruiting
Effect of Marjoram, Vetiver, and Lavender Oil in the Treatment of Bruxism
Bruxism, Bruxism, Sleep
Recruiting
Bruxism Therapy of Facial Pain
Bruxism, Bruxism, Sleep-Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metehan Yana, PhD study director
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, Sleep, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.