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.

Study Overview

• Status: Completed
• Conditions: Bruxism, Sleep
• Intervention / Treatment: Diagnostic test: Ultrasonography

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

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Turkey
  • Etlik
    • Ankara, Etlik, Turkey, 06010
      • Ankara Yıldırım Beyazıt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients between the ages of 7 and 12, with mixed dentition, class I occlusion and diagnosed with probable bruxism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Patients between the ages of 7 and 12, with mixed dentition, class I occlusion and diagnosed with probable bruxism	Diagnostic test: Ultrasonography; Ultrasonographic evaluation of the masseter muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle thickness measurement	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.	from the beginning to the third month

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: child; bruxism; occlusal splint; masseter muscle; USG
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Mental Disorders; Tooth Diseases; Sleep Wake Disorders; Parasomnias; Bruxism; Sleep Bruxism
• Other Study ID Numbers: AYBU-DHF-ZBA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No