Niğde Ömer Halisdemir University Faculty of Dentistry
Niğde, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07548502
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.
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Request Info10 year–12 year
All sexes
Interventional
Not applicable
Niğde, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.
Time frame: Baseline, 3 months, 6 months
Change in masseter muscle thickness (measured by ultrasonography)
Time frame: Baseline, 3 months, 6 months
Changes in bruxism-related symptoms including muscle pain, fatigue, and headache will be assessed using a Wong-Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS consists of a scale ranging from 0 (no hurt) to 10 (hurt worst). Higher scores indicate greater symptom severity.
Time frame: Baseline, 3 months, 6 months
Temporomandibular joint (TMJ) findings will be assessed by clinical examination, including the presence of joint sounds (clicking/crepitation), mandibular deviation or deflection during opening, and pain on palpation. Each finding will be recorded as present or absent. The number of positive findings per participant will be calculated, with higher values indicating greater TMJ involvement.
Contact information is provided by the study sponsor or research team.
Aycan Dal Dönertaş
CONTACT
Serkan Yılmaz
CONTACT
Nigde Omer Halisdemir University
Other
Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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