Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07664215
Lead Sponsor Damascus University
Conditions Malocclusion Class II, CLASS II DIVISION 1 MALOCCLUSION
Enrollment 6 participants
Start Date 2025-07-01
Primary Completion 2026-04-27 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-24