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Recruiting Not applicable NCT07548502

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

No applicable phase (e.g. observational)
Conditions: Bruxism Bruxism, Sleep-Related

Sponsor: Nigde Omer Halisdemir University

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Occlusal Splint (Night Guard)
DEVICE
Locations 1
Turkey (1)
Niğde Ömer Halisdemir University Faculty of Dentistry
Niğde
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
12 Years
Healthy volunteers
No
Start date
15.03.2026
Completion date
01.10.2026
Registry ID
NCT07548502
Source
clinicaltrials.gov
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