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

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

NCT06894342•Ankara Yildirim Beyazıt University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

7 - 12 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Ankara Yıldırım Beyazıt University

Ankara, Etlik, Turkey (Türkiye)

Key Dates

Start Date

February 1, 2022

Primary Completion Date

June 28, 2024

Completion Date

June 28, 2024

Last Updated

April 22, 2025

Enrollment

ACTUAL participants

Conditions

Bruxism, Sleep

Interventions

Ultrasonography

DIAGNOSTIC_TEST

Pain and Mobility in Children With Sleep Bruxism

NCT06937333

Bruxism, Sleep

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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