Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
| Registry | NCT07548502 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Nigde Omer Halisdemir University (Other) |
| Conditions | Bruxism, Bruxism, Sleep-Related |
| Interventions | Occlusal Splint (Night Guard) (Device) |
| Dates | start 2026-03-15, primary completion 2026-09-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-04-23, last updated 2026-04-29 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Bruxism All trials for Bruxism, Sleep-Related All trials of Occlusal Splint (Night Guard)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Night Guard Treatment | Experimental | Device: Occlusal Splint (Night Guard) |
Sex: All, ages: 10 Years to 12 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Niğde Ömer Halisdemir University Faculty of Dentistry | Niğde | Turkey (Türkiye) | Recruiting |