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Completed

NCT Number: NCT06894342

Ultrasonographic Evaluation of the Effect of Occlusal Splint Treatment on Masseter Muscle Thickness in Children With Sleep Bruxism:A Clinical Pilot Study

The aim of this study was to evaluate the effectiveness of occlusal splint in pediatric bruxist patients by ultrasonic measurements of masseter muscle thickness and pain perception.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University

Ankara, Etlik, 06010, Turkey (Türkiye)

About this study

The aim of this study was to evaluate the effectiveness of occlusal splint by ultrasonographic measurements of masseter muscle thickness and pain perception in a group of pediatric bruxist patients. The study included patients aged 7 to 12 years, all in the mixed dentition period, with class I occlusion and diagnosed with probable bruxism. A 2 mm thick soft occlusal splint was prepared for each patient. Ultrasonic measurements were used to assess the thickness of the masseter muscle (MMT) at baseline, one, two and three months.Visual Analog Scale (VAS) was also used to record subjective pain measurements. Repeated-measures ANOVA and Friedman test were used in the statistical analysis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptoms of tooth clenching or grinding when sleeping at night or during the day, including headaches in the morning, as reported by parents during anamnesis.
  • Attrition-type tooth wear, as well as discomfort, fatigue, and/or pain in the jaw muscles when palpated during a clinical examination. The clinical diagnosis of attrition was based on the following findings:
  • Shiny and flat facets.
  • The enamel and dentin wear at the same pace.
  • Wear patterns on opposing teeth's occlusal surfaces.
  • Possible breakage of cusps or restorations.
  • Impressions on the cheeks, tongue, or lips.

Exclusion criteria

  • Children with any chronic/systemic/psychological disease, presence of TMD symptoms, lack of posterior teeth that may cause unilateral chewing, use of any medication that may affect muscle activity, dental malocclusions (any skeletal jaw problems in anteroposterior and vertical dimensions) and ongoing orthodontic treatment

Treatment and study plan

ultrasonography

Diagnostic Test

Ultrasonographic evaluation of the masseter muscle

Primary outcomes

  1. muscle thickness measurement

    Time frame: from the beginning to the third month

    Masseter muscle thicknes was measured from a single position at the thickest part of the muscle, close to the occlusal plane and midway between the zygomatic arch and the gonial angle. Masseter muscle thicknes was evaluated bilaterally, in both the relaxed and contracted (maximum biting) positions.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2025
Registry last updated
Apr 22, 2025

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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