NCT06937333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 10, 2025

Last Update Submit

April 17, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Sleep bruxism

Children diagnosed with sleep bruxism were included in this study.

Control Group

Age- and sex-matched healthy children were included.

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with bruxism and healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Metehan Yana, PhD

    Karabuk University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, PT, PhD

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 22, 2025

Study Start

June 15, 2024

Primary Completion

February 15, 2025

Study Completion

April 1, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations