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

NCT06949527 | Completed

• 2 other identifiers: ANK-DHF-OBM-202536290600/78
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Open Bite Treatment; Masseter Muscle; Ultrasound Imaging; Sonoelastography; Skeletal Anchorage; Vertical Elastics; Functional Orthodontic Appliance; Cephalometric Analysis

Outcome Measures

Primary Outcomes (1)

• Change in masseter muscle thickness measured by ultrasonography

  Masseter muscle thickness (in millimeters) will be measured at rest and during maximal clenching using ultrasonography at three time points: baseline (T0), 6 months (T1), and 12 months (T2).

  Baseline, 6 months, and 12 months

Secondary Outcomes (1)

• Change in masseter muscle stiffness assessed by sonoelastography

  Baseline, 6 months, and 12 months

Study Arms (1)

Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics

EXPERIMENTAL

Patients were treated using a custom-made open bite activator combined with vertical elastics supported by anterior miniscrews placed between lateral and canine teeth in both jaws. The elastics applied 150g of force bilaterally and were worn for 20-22 hours per day over a 12-month period. The goal was to manage vertical skeletal development and evaluate changes in masseter muscle morphology via ultrasound and sonoelastography.

Device: Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics

Interventions

Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics DEVICE

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.

Also known as: Functional Appliance, Vertical Elastics, Mini-Implants

Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• GoGn/SN angle ≥ 36°
• Decreased overbite (dental open bite)
• In active growth phase (confirmed by hand-wrist radiograph)
• Good oral hygiene
• No prior orthodontic or orthognathic treatment

You may not qualify if:

• Presence of systemic disease or craniofacial deformity
• Poor oral hygiene
• Non-compliance with appliance wear
• Previous use of skeletal anchorage devices

Sponsors & Collaborators

• Murat Kaan Erdem: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Çankaya, 06500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Murat K Erdem, PhD, DDS

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, DDS

Model Details: Participants received treatment with an open bite activator combined with vertical elastics supported by anterior skeletal anchorage in a single group.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: January 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

TU (1)