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

NCT ID: NCT06949527

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-01-15

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.

Detailed Description

This prospective clinical study investigates the dentofacial and muscular effects of a combined orthopedic treatment method in patients with skeletal open bite. The intervention includes the use of an open bite activator appliance along with anterior skeletal anchorage-supported vertical elastics. The study was conducted at Ankara University Faculty of Dentistry, Orthodontics Department, and received ethical approval (Approval No: 36290600/78).

A total of 24 growing individuals (14 females, 10 males) with increased vertical facial pattern (GoGn/SN ≥ 36°) were treated over a 12-month period. Patients received custom-made open bite activators designed to eliminate occlusal contact in the anterior region and redirect functional forces posteriorly. Miniscrews were placed between the lateral and canine teeth in both the maxilla and mandible, and vertical elastics were applied between these skeletal anchorage points with a force of 150 grams on each side, worn for 20-22 hours daily.

Masseter muscle changes were assessed using ultrasonography and sonoelastography at three time points: baseline (T0), interim (6 months, T1), and end of treatment (12 months, T2). Muscle thickness and stiffness (elasticity) were measured bilaterally during rest and maximal clenching. Cephalometric radiographs were obtained at T0 and T2 to evaluate skeletal and dentoalveolar changes, including SNA, SNB, ANB angles, overbite, U1-PP, L1-MP, and other relevant vertical and angular measurements.

Statistical analysis revealed significant increases in masseter muscle thickness during the treatment period, especially between T0 and T1. Stiffness values peaked at T1 and slightly decreased at T2, but remained higher than baseline. Cephalometric findings showed improvements in overbite and reductions in vertical growth tendencies, including significant changes in GoGn/SN and PP-MP angles.

This study demonstrates that combined functional appliance and skeletal anchorage-based vertical control therapy can positively influence muscle structure and dentofacial morphology in hyperdivergent skeletal open bite cases. Ultrasonography and sonoelastography proved to be reliable, non-invasive methods for assessing soft tissue changes in orthodontic treatment.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics

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.

Group Type: EXPERIMENTAL

Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Functional Appliance; Vertical Elastics; Mini-Implants

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Murat Kaan Erdem

OTHER

Sponsor Role: lead

Responsible Party

Murat Kaan Erdem

PhD, DDS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Murat K Erdem, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

Ankara University Faculty of Dentistry

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

36290600/78

Identifier Type: OTHER

Identifier Source: secondary_id

ANK-DHF-OBM-2025

Identifier Type: -

Identifier Source: org_study_id