Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-12
SponsorNigde Omer Halisdemir University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 10-12 years
Diagnosis of bruxism based on parental report and clinical findings
Willingness to participate
Parental consent and child assent obtained
Disqualifiers
Missing posterior teeth causing unilateral chewing
History of psychological disorders
Neurological disorders or craniofacial abnormalities
Use of medications affecting muscle activity
Trial design
Design model
Single group
Treatments tested in this trial
Occlusal Splint (Night Guard)
DeviceParticipants will receive a custom-made night guard and will be instructed to use it regularly during sleep.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Night Guard TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in masseter muscle thickness
Change in masseter muscle thickness (measured by ultrasonography)
Time frame
Baseline, 3 months, 6 monthsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov