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

NCT06894342 | Completed

• 1 other identifier: AYBU-DHF-ZBA-01
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bruxism, Sleep

Keywords

bruxism; child; USG; masseter muscle; occlusal splint

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Group

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

Diagnostic Test: Ultrasonography

Interventions

Ultrasonography DIAGNOSTIC_TEST

Ultrasonographic evaluation of the masseter muscle

Study Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: February 1, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)