An interventional study of Occlusal Splint (Night Guard) in Bruxism and Bruxism, Sleep-Related, sponsored by Nigde Omer Halisdemir University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Treatment
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.
62 studies on the registry are indexed under Sleep Bruxism; 11 are open to participants now.
This study's planned enrollment of 20 is below the median of 39 across 38 interventional studies indexed under Sleep Bruxism.
Browse Sleep Bruxism studies →Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.
Compared within Sleep Bruxism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bruxism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Device: Occlusal Splint (Night Guard)
Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.
Change in masseter muscle thickness
Change in masseter muscle thickness (measured by ultrasonography)
Time frame: Baseline, 3 months, 6 months
Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale
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
Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)
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.
Time frame: Baseline, 3 months, 6 months
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Nigde Omer Halisdemir University