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

NCT07664215 | Completed DMC

• 1 other identifier: UDDS-2026-Ortho-4
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Class II division 1; protrusion; Bi-dimensional archwire; retraction; upper anterior teeth retraction; en masse retraction

Outcome Measures

Primary Outcomes (1)

• Change in the monthly rate of maxillary anterior en-masse retraction

  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 Outcomes (1)

• Change in maxillary incisor torque

  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.

Study Arms (1)

Bi-dimensional archwire

EXPERIMENTAL

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

Interventions

Bi-dimensional archwire PROCEDURE

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.

Bi-dimensional archwire

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

Location

Related Publications (5)

• Gnaneswar SM, Sridhar P. Comparison of dual-dimensional and rectangular wires in terms of space closure and anchorage loss during retraction with miniimplants: A prospective clinical study. J Dent Res Dent Clin Dent Prospects. 2020 Winter;14(1):54-60. doi: 10.34172/joddd.2020.008.

  PMID: 32454959 BACKGROUND

• Hamanaka R, Cantarella D, Lombardo L, Karanxha L, Del Fabbro M, Siciliani G, Yoshida N. Dual-section versus conventional archwire for en-masse retraction of anterior teeth with direct skeletal anchorage: a finite element analysis. BMC Oral Health. 2021 Feb 25;21(1):87. doi: 10.1186/s12903-021-01443-0.

  PMID: 33632190 BACKGROUND

• Li Y, Tang N, Xu Z, Feng X, Yang L, Zhao Z. Bidimensional techniques for stronger anterior torque control in extraction cases: a combined clinical and typodont study. Angle Orthod. 2012 Jul;82(4):715-22. doi: 10.2319/082811-550.1. Epub 2011 Dec 8.

  PMID: 22149540 BACKGROUND

• Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.

  PMID: 18617099 BACKGROUND

• Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.

  PMID: 23787192 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abdulmalek M. H. Almasri, DDS

  Damascus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2025
• Primary Completion: April 27, 2026
• Study Completion: May 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)