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A Novel Bi-dimensional Archwire for Miniscrew-supported En-masse Retraction

NCT07664215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-06-24

No results posted yet for this study

Summary

This study aims to provide a preliminary clinical evaluation of a novel bi-dimensional archwire used during miniscrew-supported en-masse retraction of the maxillary anterior teeth. Adult patients with Class II Division 1 malocclusion requiring extraction of the maxillary first premolars will be screened at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible participants will receive fixed orthodontic treatment followed by en-masse retraction using a custom-made laser-welded bi-dimensional stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments. Retraction will be supported by orthodontic miniscrews and nickel-titanium closed-coil springs. The main outcome will be the monthly rate of maxillary anterior retraction assessed on three-dimensional digital dental models. A secondary outcome will be the change in maxillary incisor torque assessed on lateral cephalometric radiographs. This pilot study is intended to generate preliminary clinical data regarding the feasibility and performance of this novel archwire design.

Conditions

  • Malocclusion Class II
  • CLASS II DIVISION 1 MALOCCLUSION

Interventions

PROCEDURE

Bi-dimensional archwire

The retraction procedure is going to be conducted using a bi-dimensional archwire which is a single continuous stainless-steel assembly composed of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments joined by laser welding.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Abdulmalek M. H. Almasri, DDS · Damascus University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-04-27
Completion
2026-05-01

Countries

  • Syria

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 NCT07664215 on ClinicalTrials.gov