Pain and Mobility in Children With Sleep Bruxism | NCT06937333

Studies
Pain and Mobility in Children With Sleep Bruxism

NCT06937333

Sponsor

Karabuk University

Status

Completed

Last Update Posted

Apr 22, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Bruxism, Sleep

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2024Actual

Primary Completion Date

Feb 15, 2025Actual

Completion Date

Apr 1, 2025Actual

First Submitted Date

Apr 10, 2025

First Submission Date that Met QC Criteria

Apr 17, 2025

First Posted Date

Apr 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep bruxism		Children diagnosed with sleep bruxism were included in this study.
Control Group		Age- and sex-matched healthy children were included.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain pressure threshold	Pain pressure threshold was evaluated the algometer.	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,	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.	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.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with bruxism and healthy controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Metehan Yana, PhD	Karabuk University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karabük University		Karabük		78000	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32223910	Result	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.

ID	Term
D002012	Bruxism
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D020447	Parasomnias