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Distalization With Aligners: Anchorage Options

NCT06631131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-02-05

No results posted yet for this study

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

Interventions

DEVICE

Distalization with clear aligners supported by Class II elastics

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.

DEVICE

Distalization with clear aligners supported by miniscrew

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.

Sponsors & Collaborators

  • Bezmialem Vakif University

    lead OTHER

Principal Investigators

  • Ezgi Sunal Aktürk, Assistant professor · University of Health Sciences, Hamidiye Faculty of Dental Medicine, Department of Orthodontics

  • Ezgi Kösen, PhD student · Bezmialem Vakif University,Institute of Health Sciences, Department of Orthodontics,

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2023-08-30
Completion
2023-12-26
FDA Device
Yes

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 NCT06631131 on ClinicalTrials.gov