Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07548502
Enrollment
20
Registered
2026-04-23
Start date
2026-03-15
Completion date
2026-10-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Bruxism, Sleep-Related

Keywords

Pediatric bruxism, Masseter muscle thickness, Ultrasonography, Night Guard

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.

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.

Interventions

DEVICEOcclusal Splint (Night Guard)

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

Sponsors

Nigde Omer Halisdemir University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in masseter muscle thicknessBaseline, 3 months, 6 monthsChange in masseter muscle thickness (measured by ultrasonography)

Secondary

MeasureTime frameDescription
Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating ScaleBaseline, 3 months, 6 monthsChanges 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.
Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)Baseline, 3 months, 6 monthsTemporomandibular 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTAycan Dal Dönertaş
aycandal@outlook.com+903382252595
CONTACTSerkan Yılmaz
serkanyilmaza@gmail.com+905378970192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026