Treatment of Skeletal Open Bite With Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics

NCT06936371 | Completed

• 2 other identifiers: AUFDT-ORT-2021-2236290600/22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated a new treatment approach for skeletal open bite in growing individuals using an open bite activator combined with anterior skeletal anchorage-supported vertical elastics. An open bite is a condition where the front teeth don't touch when the back teeth are closed together, creating a gap. Traditional treatments often use extraoral appliances (devices worn outside the mouth), which can be uncomfortable and aesthetically unappealing, leading to poor patient compliance. We included 24 growing patients (14 females, 10 males) aged 12-14 years with skeletal open bite. All participants received an open bite activator (a removable functional appliance) and mini-screws placed between the upper and lower lateral and canine teeth. Vertical elastics were connected between these mini-screws, applying 150g of force for 20-22 hours daily over 12 months. Lateral cephalometric radiographs (specialized X-rays) were taken before treatment and after 12 months to evaluate changes in facial bone structure and tooth positions. Our results showed successful correction of open bite with an average increase in overbite of 3.35mm. We observed favorable skeletal changes including clockwise rotation of the maxilla (upper jaw), counterclockwise rotation of the mandible (lower jaw), and decreased vertical facial dimensions. This treatment approach offers a viable alternative to conventional methods that rely on extraoral appliances, potentially improving patient comfort and compliance. The protocol successfully addresses both skeletal and dental components of open bite malocclusion in growing patients.

Conditions

Skeletal Open Bite; Vertical Maxillary Excess; Hyperdivergent Growth Pattern; Long Face Syndrome

Keywords

Open Bite Activator; Skeletal Anchorage; Mini-screws; Vertical Elastics; Orthodontic Treatment; Anterior Open Bite; Bite Correction; Dentofacial Effects; Cephalometric Analysis; Growing Patients; Non-extraction Treatment; Functional Appliance; Vertical Dimension Control

Outcome Measures

Primary Outcomes (1)

• Change in GoGn/SN Angle (Mandibular Plane Angle) from Baseline to 12 Months

  This outcome assesses the change in the mandibular plane angle (GoGn/SN) using lateral cephalometric radiographs taken at the beginning of treatment (T0) and after 12 months of therapy (T1). A decrease in the GoGn/SN angle indicates counterclockwise rotation of the mandible, which is a favorable skeletal change in the treatment of skeletal open bite. Measurements were performed using standardized digital cephalometric analysis software (Dolphin Imaging 11.95).

  Baseline to 12 months post-treatment

Study Arms (1)

Functional Appliance and Skeletal Anchorage Group

EXPERIMENTAL

This arm includes growing individuals with skeletal open bite treated using a combination of an open bite activator (functional appliance) and vertical intermaxillary elastics supported by anterior skeletal anchorage (mini-screws placed between lateral and canine teeth in both jaws). The appliance was worn full-time for 12 months. Cephalometric changes were evaluated before and after treatment to assess skeletal and dentoalveolar effects without the use of extraoral appliances.

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

Interventions

Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics DEVICE

Participants received a removable open bite activator constructed with the mandible opened beyond the freeway space and combined with vertical intermaxillary elastics applying 150g of force, supported by mini-screws placed between the lateral and canine teeth in both the maxilla and mandible. The appliance was worn 20-22 hours daily for 12 months. This approach aimed to treat skeletal open bite without using extraoral appliances by promoting anterior mandibular rotation and inhibiting posterior vertical dentoalveolar development.

Also known as: Functional Appliance with Mini-screw-Supported Elastics, Anterior Skeletal Anchorage

Functional Appliance and Skeletal Anchorage Group

Eligibility Criteria

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

You may qualify if:

• Growing individuals aged 12-14 years
• Diagnosis of skeletal open bite with GoGn/SN angle ≥36°
• Dentally reduced or negative overbite
• Ongoing growth and development (confirmed with hand-wrist radiographs)
• Good oral hygiene
• No prior orthodontic treatment or orthognathic surgery
• No systemic disease or craniofacial deformity
• Informed consent obtained from participant and parent/guardian

You may not qualify if:

• Presence of any craniofacial anomaly or systemic condition affecting craniofacial growth
• History of prior orthodontic treatment or jaw surgery
• Poor oral hygiene
• Non-compliance with appliance wear protocol
• Outside the age range of 12-14 years

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Çankaya, 06500, Turkey (Türkiye)

Location

Study Officials

• Elif Değirmenci, DDS, PhD

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This prospective interventional study employed a single-group design where all participants received the same treatment protocol: open bite activator combined with skeletal anchorage-supported vertical elastics. Participants were evaluated at baseline (T0) and after 12 months of treatment (T1).

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

TU (1)