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

June 17, 2026 updated by: Damascus University

Preliminary Clinical Evaluation of a Novel Bi-dimensional Archwire During Miniscrew-Supported En-masse Retraction of the Maxillary Anterior Teeth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a prospective single-arm pilot clinical trial to provide an initial clinical evaluation of a novel bi-dimensional archwire specifically developed for miniscrew-supported en-masse retraction of the maxillary anterior teeth. In adult orthodontic patients requiring extraction-based treatment, effective space closure depends not only on anchorage control, but also on the ability of the active retraction system to maintain acceptable control of the maxillary incisors during sliding mechanics. Conventional continuous rectangular stainless-steel archwires provide rigidity, but they may still be associated with frictional resistance, wire deformation, and incomplete torque control during retraction.

The archwire investigated in this study was newly developed as 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. The design was intended to combine greater anterior stiffness, to support better torque control of the maxillary incisors, with reduced posterior friction and binding during sliding mechanics. The intervention was applied under direct skeletal anchorage using self-drilling orthodontic miniscrews inserted bilaterally between the maxillary second premolars and first molars. Retraction was performed using nickel-titanium closed-coil springs delivering approximately 250 g of force per side.

Eligible participants were adult patients with skeletal Class II malocclusion and Class II Division 1 dental malocclusion who required extraction of the maxillary first premolars and en-masse retraction of the maxillary anterior teeth as part of their treatment plan. After leveling and alignment, the novel bi-dimensional archwire was inserted and the retraction phase was initiated. Participants were followed prospectively until completion of the en-masse retraction phase.

The primary outcome of the study was the monthly rate of maxillary anterior en-masse retraction assessed on three-dimensional digital dental models. The secondary outcome was the change in maxillary incisor torque measured on standardized lateral cephalometric radiographs using the bracket-archwire angle. This pilot trial was undertaken to determine whether this newly developed archwire could function as a clinically feasible biomechanical option and to generate preliminary outcome estimates for future randomized controlled trials.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
      • Damascus, Syria, DM20AM19
        • Department of Orthodontics, Faculty of Dentistry, University of Damascus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bi-dimensional archwire
Participants will be treated using a novel bi-dimensional stainless-steel archwire during miniscrew-supported en-masse retraction of the maxillary anterior teeth
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the monthly rate of maxillary anterior en-masse retraction
Time Frame: Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.
The amount of maxillary anterior retraction is assessed on three-dimensional digital dental models using the distance between the incisal edge of the maxillary central incisors and the medial point of the third palatal rugae as a stable intraoral reference. The monthly retraction rate is calculated in millimeters per month by dividing the amount of anterior retraction by the corresponding duration of the retraction interval.
Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maxillary incisor torque
Time Frame: Time 0: completion of leveling and alignment stage which is expected to occur within three months, and Time Final: completion of en-masse retraction stage which occurs within 9 - 10 months following the end of the leveling and alignment stage.
Maxillary incisor torque is assessed on standardized lateral cephalometric radiographs using the bracket-archwire angle. A tangent is drawn along the base of the maxillary central incisor bracket, and another tangent is drawn parallel to and superimposed on the working archwire. The obtuse angle formed between the two tangents is measured, and the actual torque value is calculated by subtracting 90° from this angle. The change in torque is determined by comparing the measurements recorded at T0 and T1.
Time 0: completion of leveling and alignment stage which is expected to occur within three months, and Time Final: completion of en-masse retraction stage which occurs within 9 - 10 months following the end of the leveling and alignment stage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Abdulmalek M. H. Almasri, DDS, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

April 27, 2026

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

June 13, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-2026-Ortho-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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