Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Occlusal Splint (Night Guard).
- Who it may be relevant to
- Registry conditions: Bruxism, Bruxism, Sleep-Related. Basic parameters: 10 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
Overview
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
- Device Occlusal Splint (Night Guard)
Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.
Primary outcome measures
- Change in masseter muscle thickness [Time frame: Baseline, 3 months, 6 months]
Secondary outcome measures (2)
- Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale [Time frame: 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]
Eligibility criteria
Inclusion criteria
- Children aged 10-12 years
- Diagnosis of bruxism based on parental report and clinical findings
- Willingness to participate
- Parental consent and child assent obtained
Exclusion criteria
- Missing posterior teeth causing unilateral chewing
- History of psychological disorders
- Neurological disorders or craniofacial abnormalities
- Use of medications affecting muscle activity
- Presence of skeletal malocclusions
- Ongoing orthodontic treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Niğde Ömer Halisdemir University Faculty of Dentistry — Niğde
Identifiers
NCT: NCT07548502 · NigdeOHU-BruksizmUSG