Night guard use and jaw muscle (masseter) thickness in 10–12-year-olds with bruxism
Official title: Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
Run by Nigde Omer Halisdemir University · NCT07548502 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 12 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Niğde) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | September 2026 |
| Study ends | October 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07548502 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Niğde Ömer Halisdemir University Faculty of Dentistry
Niğde, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Aycan Dal Dönertaş
- Email: aycandal@outlook.com
- Phone: +903382252595
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Bruxism Therapy with a Splint for Facial Pain
This study tests whether wearing a night-time occlusal splint changes jaw muscle activity in adults with temporomandibular disorders and chronic jaw pain, using a portable EMG device to track activity over 24 hours.
-
Bruxism, Anxiety, and Periodontal Health in Dental Students
This project will see if bruxism and anxiety are linked to gum health in fourth- and fifth-year dental students.
-
Somatosensory awareness training versus jaw and posture exercises for awake bruxism
This trial will test whether somatosensory awareness training or jaw and posture exercises help adults with daytime teeth clenching (awake bruxism) reduce pain and improve jaw function and sensory processing.
-
Diadynamic current combined with jaw exercises for bruxism
This trial will see if adding diadynamic electrical stimulation to a 6-week, thrice-weekly jaw exercise program reduces pain and improves jaw strength and movement in adults with bruxism.
-
Chlorzoxazone versus orphenadrine citrate for relieving bruxism-related jaw and facial pain
This trial will test whether chlorzoxazone or orphenadrine citrate better reduces jaw and facial pain in people who grind their teeth (bruxism).
-
Mobile prompts and education to reduce jaw clenching and awake bruxism
This trial tests whether a one-week mobile prompt program combined with an educational video helps adults with temporomandibular disorder (TMD) or awake bruxism reduce jaw clenching and masticatory muscle activity compared with education alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.