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Effects of Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle

NCT06949527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-29

No results posted yet for this study

Summary

This clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. A total of 24 growing individuals with increased vertical skeletal pattern were treated with a functional appliance and intermaxillary vertical elastics supported by miniscrews placed in the anterior region. Ultrasonographic and sonoelastographic assessments were performed at baseline, 6 months, and 12 months to measure changes in masseter muscle thickness and stiffness. Cephalometric radiographs were also used to evaluate dentofacial structural changes. This study aims to provide insight into the soft tissue changes associated with functional orthopedic treatment in hyperdivergent patients.

Conditions

  • Hyperdivergent Facial Pattern
  • Skeletal Open Bite
  • Hyperdivergent Growth Pattern
  • Anterior Open Bite

Interventions

DEVICE

Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics

A custom-made acrylic open bite activator was fabricated for each participant, with the bite registered 3-4 mm above freeway space. Miniscrews were placed between the lateral and canine teeth in both jaws. Vertical elastics (150g force) were applied bilaterally between miniscrews and the appliance. The intervention aimed to reduce vertical growth in posterior regions and stimulate anterior dentoalveolar development while improving masseter muscle morphology.

Sponsors & Collaborators

  • Murat Kaan Erdem

    lead OTHER

Principal Investigators

  • Murat K Erdem, PhD, DDS · Ankara University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06949527 on ClinicalTrials.gov