NCT07744685

Brief Summary

External apical root resorption is a possible side effect of fixed orthodontic treatment, particularly in the upper front teeth. This randomized clinical trial was conducted to compare the amount and timing of root resorption associated with three different methods of retracting the upper anterior teeth using miniscrew anchorage. Sixty adult patients with Class II Division 1 malocclusion who required extraction of the upper first premolars were randomly allocated to one of three groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group. In all groups, the six upper anterior teeth were retracted together with the support of orthodontic miniscrews. Panoramic radiographs were obtained before treatment, after completion of leveling and alignment, and after completion of en-masse retraction. Root and crown lengths were measured on these radiographs to estimate external apical root resorption during the leveling and alignment phase, during the retraction phase, and over the complete observation period. The study also compared the pattern of resorption among the upper canines, lateral incisors, and central incisors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 23, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • External Apical Root Resorption of the Maxillary Anterior Teeth

    External apical root resorption was assessed separately for the six maxillary anterior teeth by measuring changes in corrected root length on digital panoramic radiographs using ImageJ software. Crown length was used as a stable reference to correct for differences in radiographic magnification. Root resorption was expressed in millimeters, and the total amount was calculated directly from the initial and final radiographs rather than by adding the interval measurements.

    Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.

Study Arms (3)

Bidimensional Bracket Group

EXPERIMENTAL

Participants will be treated using a bidimensional fixed orthodontic appliance during leveling, alignment, and en-masse retraction.

Procedure: Bidimensional Bracket System

Hybrid Dual-Section Archwire Group

EXPERIMENTAL

Participants will be treated using a hybrid dual-section archwire during miniscrew-supported en-masse retraction.

Procedure: Hybrid Dual-Section Archwire

Conventional Sliding Mechanics Group

ACTIVE COMPARATOR

Participants will be treated using conventional fixed orthodontic sliding mechanics during miniscrew-supported en-masse retraction

Procedure: Conventional Sliding Mechanics

Interventions

Fixed orthodontic treatment will be performed using 0.018-inch slot brackets from canine to canine and 0.022-inch slot brackets on the posterior teeth. After leveling and alignment, en-masse retraction will be performed on a 0.018 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.

Bidimensional Bracket Group

Fixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out using a customized stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior section and 0.016 × 0.022-inch posterior sections, with the transitions located distal to the maxillary canines. Bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g per side will be used.

Hybrid Dual-Section Archwire Group

Fixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out on a continuous 0.019 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.

Conventional Sliding Mechanics Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-30 years.
  • Class II Division 1 dental malocclusion according to Angle classification
  • Mild-to-moderate skeletal Class II discrepancy, with an ANB angle greater than 4° and not exceeding 7°.
  • Overjet ranging from 5 to 9 mm.
  • Presence of all six maxillary anterior teeth.
  • Maxillary anterior teeth fully erupted and with complete root formation.

You may not qualify if:

  • Patients with previous orthodontic treatment.
  • Missing permanent maxillary teeth.
  • Active periodontal disease.
  • History of trauma to any maxillary anterior tooth.
  • Previous endodontic treatment of any maxillary anterior tooth.
  • Periapical pathology involving any maxillary anterior tooth.
  • Extensive coronal restorations that could interfere with crown-length measurement.
  • Radiographic evidence of pre-existing root resorption before orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Damascus, DM20AM19, Syria

Location

Related Publications (5)

  • Linge BO, Linge L. Apical root resorption in upper anterior teeth. Eur J Orthod. 1983 Aug;5(3):173-83. doi: 10.1093/ejo/5.3.173. No abstract available.

    PMID: 6578039BACKGROUND
  • Levander E, Malmgren O. Evaluation of the risk of root resorption during orthodontic treatment: a study of upper incisors. Eur J Orthod. 1988 Feb;10(1):30-8. doi: 10.1093/ejo/10.1.30. No abstract available.

    PMID: 3162877BACKGROUND
  • Futyma-Gabka K, Rozylo-Kalinowska I, Piskorz M, Bis E, Borek W. Evaluation of root resorption in maxillary anterior teeth during orthodontic treatment with a fixed appliance based on panoramic radiographs. Pol J Radiol. 2022 Oct 5;87:e545-e548. doi: 10.5114/pjr.2022.120512. eCollection 2022.

    PMID: 36420127BACKGROUND
  • Dudic A, Giannopoulou C, Leuzinger M, Kiliaridis S. Detection of apical root resorption after orthodontic treatment by using panoramic radiography and cone-beam computed tomography of super-high resolution. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):434-7. doi: 10.1016/j.ajodo.2008.10.014.

    PMID: 19361727BACKGROUND
  • Artun J, Smale I, Behbehani F, Doppel D, Van't Hof M, Kuijpers-Jagtman AM. Apical root resorption six and 12 months after initiation of fixed orthodontic appliance therapy. Angle Orthod. 2005 Nov;75(6):919-26. doi: 10.1043/0003-3219(2005)75[919:ARRSAM]2.0.CO;2.

    PMID: 16448232BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohammad Younis Hajeer

    Department of Orthodontics, Faculty of Dentistry, University of Damascus

    STUDY DIRECTOR
  • Abdulmalek M. H. Almasri

    Department of Orthodontics, Faculty of Dentistry, University of Damascus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 4, 2026

Study Start

July 2, 2025

Primary Completion

June 23, 2026

Study Completion

June 28, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations