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NCT Number: NCT07548502

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

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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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merdan Doğan

CONTACT

[email protected]

+905422076565

About this study

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

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occlusal Splint (Night Guard)

Device

Participants will receive a custom-made night guard and will be instructed to use it regularly during sleep.

Primary outcomes

  1. Change in masseter muscle thickness

    Time frame: Baseline, 3 months, 6 months

    Change in masseter muscle thickness (measured by ultrasonography)

Secondary outcomes

  1. Change in bruxism-related clinical symptoms assessed by Wong-Baker Faces Pain Rating Scale

    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.

  2. Change in temporomandibular joint (TMJ) clinical findings (joint sounds, deviation/deflection, pain on palpation)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aycan Dal Dönertaş

CONTACT

[email protected]

+903382252595

Serkan Yılmaz

CONTACT

[email protected]

+905378970192

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Ultrasonographic Assessment of Masseter Muscles in Pediatric Bruxism: Effects of Night Guard Therapy at 3 and 6 Month Intervals

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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