Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism

April 23, 2026 updated by: Nigde Omer Halisdemir University

Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-group follow-up study is designed to evaluate the effects of night guard use on bruxism symptoms and masseter muscle thickness in children aged 10-12 years. A total of 20 children diagnosed with bruxism based on parental reports and clinical examination will be included. Clinical findings, including tooth wear, muscle tenderness, temporomandibular joint findings, and parafunctional habits, will be recorded.

Masseter muscle thickness will be measured bilaterally using ultrasonography under standardized conditions at baseline, 3 months, and 6 months. Following baseline evaluation, a custom-made night guard will be fabricated for each participant and regular use will be recommended.

Changes in clinical symptoms and muscle thickness over time will be analyzed. Ultrasonographic measurements will be performed using a standardized protocol by an experienced dentomaxillofacial radiologist. The study does not include a control group. All procedures are non-invasive and do not involve ionizing radiation.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Niğde, Turkey (Türkiye)
        • Recruiting
        • Niğde Ömer Halisdemir University Faculty of Dentistry
        • Contact:

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Missing posterior teeth causing unilateral chewing
  2. History of psychological disorders
  3. Neurological disorders or craniofacial abnormalities
  4. Use of medications affecting muscle activity
  5. Presence of skeletal malocclusions
  6. Ongoing orthodontic treatment

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Night Guard Treatment
Device: Occlusal Splint (Night Guard)
Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in masseter muscle thickness
Time Frame: Baseline, 3 months, 6 months
Change in masseter muscle thickness (measured by ultrasonography)
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale
Time Frame: Baseline, 3 months, 6 months
Changes in bruxism-related symptoms including muscle pain, fatigue, and headache will be assessed using a Wong-Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS consists of a scale ranging from 0 (no hurt) to 10 (hurt worst). Higher scores indicate greater symptom severity.
Baseline, 3 months, 6 months
Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)
Time Frame: Baseline, 3 months, 6 months
Temporomandibular joint (TMJ) findings will be assessed by clinical examination, including the presence of joint sounds (clicking/crepitation), mandibular deviation or deflection during opening, and pain on palpation. Each finding will be recorded as present or absent. The number of positive findings per participant will be calculated, with higher values indicating greater TMJ involvement.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

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)

March 15, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NigdeOHU-BruksizmUSG

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

Clinical Trials on Occlusal Splint (Night Guard)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe