Distalization With Aligners: Anchorage Options

NCT06631131 | Completed FDA Device

• 1 other identifier: 40173
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To compare the dentoskeletal effects of Class II elastic anchorage and infrazygomatic crest (IZC) miniscrew anchorage in sequential maxillary molar distalization using clear aligners. Methods: A total of 22 patients with Angle Class II malocclusion treated with clear aligners and maxillary molar distalization were included. Based on the anchorage method patients were divided into two groups: Class II elastics (Group 1) or IZC miniscrews (Group 2). Lateral cephalometric radiographs and digital models were obtained from all patients before treatment (T0) and after distalization of the second premolars (T1) to assess skeletal and dental changes. Geomagic Control X was used to superimpose the digital models.

Conditions

Class II Malocclusion; Class II Malocclusion, Division 1

Keywords

Class II malocclusion; Clear aligners; Distalization; Miniscrew anchorage

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization with Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage

  Lateral cephalometric radiographs and digital models were obtained from all patients before treatment and after distalization of the second premolars to assess skeletal and dental changes. Digital tracing and measurements of the cephalometric radiographs were performed by the same investigator using NemoCeph software. Angular dental measurements were performed between the long axis of the teeth and the sella-nasion (S-N) plane using Image J software. Geomagic Control X was used to superimpose the digital models and measurement of dental movements.

  Patients were collected and treatmets were started up to 9 months. At 12 weeks, miniscrews were inserted in group 2 and elastics were started to be used in each group. Final data were collected up to 20 months.

Study Arms (2)

Distalization with clear aligners supported by Class II elastics

ACTIVE COMPARATOR

Group 1: these patients were treated with sequential distalization with aligners supported by Class II elastics.

Device: Distalization with clear aligners supported by Class II elastics

Distalization with clear aligners supported by miniscrew

ACTIVE COMPARATOR

Group 2: these patients were treated with sequential distalization with aligners supported by IZC miniscrews.

Device: Distalization with clear aligners supported by miniscrew

Interventions

Distalization with clear aligners supported by Class II elastics DEVICE

Sequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. ). In group 1, with the beginning of the movement of the upper first molars, Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars for supporting distalization movement.

Distalization with clear aligners supported by Class II elastics

Distalization with clear aligners supported by miniscrew DEVICE

Sequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. In group 2, IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started. The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew for supporting distalization movement.

Distalization with clear aligners supported by miniscrew

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Class II molar relationship,
• mild or moderate dental crowding on both arches,
• previous extraction or absence of the upper third molars,
• good compliance to orthodontic treatment,
• availability of initial and progress stereothography (STL) files of intraoral scans and lateral cephalometric radiographs.

You may not qualify if:

• severe dental crowding on both arches,
• Class II subdivision malocclusion,
• severe skeletal Class II malocclusion requiring orthognathic surgery,
• presence of impacted or supernumerary teeth,
• tooth extraction (except third molars),
• poor compliance to orthodontic treatment,
• craniofacial and dentofacial disorders, syndromes, or systemic diseases impacting bone metabolism or tooth movement.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overbite; Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ezgi Sunal Aktürk, Assistant professor

  University of Health Sciences, Hamidiye Faculty of Dental Medicine, Department of Orthodontics

  STUDY DIRECTOR

• Ezgi Kösen, PhD student

  Bezmialem Vakif University,Institute of Health Sciences, Department of Orthodontics,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of twenty-seven patients were initially included. However, five patients were excluded because they discontinued treatment (n=2), had poor treatment compliance (n=2), or had poor radiograph quality (n=1). Consequently, the final sample comprised 22 individuals, with 11 individuals (22 second molar, 22 first molar and 22 second premolar) in each group, ranging in age from 15 to 25. All patients were treated with clear aligners.The patients were divided into two groups, those who were treated with sequential distalization with aligners supported by Class II elastics (group 1) or IZC miniscrews (group 2).

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 8, 2024
• Study Start: December 30, 2021
• Primary Completion: August 30, 2023
• Study Completion: December 26, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)