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Completed NCT07664215

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

Conditions: Malocclusion Class II, CLASS II DIVISION 1 MALOCCLUSION

Sex: All
Ages: 18 Years – 28 Years
Healthy volunteers: No
Phase: NA
Enrollment: 6
Sponsor: Damascus University

Location: Department of Orthodontics, Faculty of Dentistry, University of Damascus Damascus

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.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18-28 years with skeletal Class II malocclusion (ANB angle 5°-7°) * Class II Division 1 dental malocclusion according to Angle classification * An average or vertical facial growth pattern * A treatment plan requiring extraction of the maxillary first premolars * A need for maxillary anterior en-masse retraction * The presence of all permanent maxillary teeth except the third molars Exclusion Criteria: * Patients with previous orthodontic treatment, * Craniofacial anomalies, systemic diseases affecting bone metabolism * Active periodontal disease * Poor oral hygiene * Missing maxillary permanent teeth, or were using * The use of medications known to influence bone metabolism

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07664215). StuddyBuddy aggregates publicly available trial information.