NCT07548502

Brief Summary

This prospective study aims to evaluate the clinical findings of bruxism and masseter muscle thickness in children aged 10-12 years using ultrasonography, and to assess the effects of night guard use on these parameters over time.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 16, 2026

Last Update Submit

April 23, 2026

Conditions

BruxismBruxism, Sleep-Related

Keywords

Pediatric bruxismMasseter muscle thicknessUltrasonographyNight Guard

Outcome Measures

Primary Outcomes (1)

  • Change in masseter muscle thickness

    Change in masseter muscle thickness (measured by ultrasonography)

    Baseline, 3 months, 6 months

Secondary Outcomes (2)

  • Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale

    Baseline, 3 months, 6 months

  • Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)

    Baseline, 3 months, 6 months

Study Arms (1)

Night Guard Treatment

EXPERIMENTAL
Device: Occlusal Splint (Night Guard)

Interventions

Occlusal Splint (Night Guard)DEVICE

Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.

Night Guard Treatment

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 10-12 years
  • Diagnosis of bruxism based on parental report and clinical findings
  • Willingness to participate
  • Parental consent and child assent obtained

You may not qualify if:

  • Missing posterior teeth causing unilateral chewing
  • History of psychological disorders
  • Neurological disorders or craniofacial abnormalities
  • Use of medications affecting muscle activity
  • Presence of skeletal malocclusions
  • Ongoing orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

BruxismSleep Bruxism

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Central Study Contacts

Aycan Dal Dönertaş

CONTACT

+903382252595aycandal@outlook.com

Serkan Yılmaz

CONTACT

+905378970192serkanyilmaza@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

TU(1)