Night guard use and jaw muscle (masseter) thickness in 10–12-year-olds with bruxism
Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
NA · Nigde Omer Halisdemir University · NCT07548502
This will test whether wearing a custom night guard changes jaw muscle (masseter) thickness and reduces bruxism symptoms in children aged 10–12.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 12 Years |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Niğde) |
| Trial ID | NCT07548502 on ClinicalTrials.gov |
What this trial studies
This prospective, single-group follow-up will enroll 20 children aged 10–12 diagnosed with bruxism by parental report and clinical examination. Bilateral masseter muscle thickness will be measured by ultrasonography at baseline, 3 months, and 6 months using a standardized protocol performed by an experienced dentomaxillofacial radiologist. After the baseline evaluation, each participant will receive a custom-made night guard and be asked to use it regularly while clinical findings (tooth wear, muscle tenderness, TMJ signs, and parafunctional habits) are recorded over time. The study has no control group and all procedures are non-invasive and free of ionizing radiation.
Who should consider this trial
Good fit: Children aged 10–12 with parental-reported and clinically confirmed bruxism who can attend follow-up visits and whose parents provide consent and the child assent.
Not a fit: Children with missing posterior teeth causing unilateral chewing, skeletal malocclusions, ongoing orthodontic treatment, neurological or psychological disorders, or using medications that affect muscle activity are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, regular night-guard use could reduce bruxism-related jaw muscle enlargement and symptoms, potentially decreasing tooth wear and jaw pain in affected children.
How similar studies have performed: Night guards have been reported to reduce bruxism symptoms in prior clinical reports, but longitudinal ultrasonographic tracking of masseter thickness in children is relatively uncommon and the single-group design is exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Niğde
- Niğde Ömer Halisdemir University Faculty of Dentistry — Niğde, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Aycan Dal Dönertaş
- Email: aycandal@outlook.com
- Phone: +903382252595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bruxism, Bruxism, Sleep-Related, Pediatric bruxism, Masseter muscle thickness, Ultrasonography, Night Guard