NCT07243509

Brief Summary

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched. This study aims to compare two groups of patients with mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°), a normal to slightly increased vertical growth pattern (Björk's sum \> 390° and \< 406°), and an overjet of 5-10 mm. Experimental group: the patients in this group will be treated in the canine retraction phase with a sliding on a round-section archwire of 0.020 inch Control group: the patients in this group. Maxillary canine distalization was carried out using sliding mechanics on a 0.019 × 0.025-inch stainless steel archwire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 14, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Canine retractionacceleration of orthodontic tooth movementBidimensioanl archwireSliding mechanics

Outcome Measures

Primary Outcomes (1)

  • Change in the Rate of Maxillary Canine Retraction

    Canine displacement is measured by projecting the canine apex and the medial end of the third palatal ruga onto the mid-palatal plane; the linear distance between these points is recorded at each time point. Monthly retraction rates are calculated by dividing the change in displacement by the corresponding interval in months. For each subject, mean monthly rates for right and left canines are determined, and the cohort retraction rate is expressed as the average across all patients.

    T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)

Secondary Outcomes (4)

  • Change in Canine Rotation

    T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)

  • Change in Anchorage Loss

    T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)

  • Change in Canine Angulation

    T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)

  • Root Resorption of the Canine

    T0: T0: 10 minutes before starting canine retraction stage; TF: At completion of canine retraction (expected to happen within 3 - 5 months)

Study Arms (2)

Canine retraction on a round cross-section archwire

EXPERIMENTAL

The patients in this group will be treated by sliding on a round cross-section archwire of 0.020-inch diameter.

Procedure: Round-cross-section archwire

Traditional canine retraction on a rectangular-cross-section archwire

ACTIVE COMPARATOR

The patients in this group will be treated using a sliding rectangular arch wire with a diameter of 0.019 × 0.025 inches.

Procedure: Rectangular-cross-section archwire

Interventions

Canines will be retracted on an archwire with a diameter of 0.20 inches.

Canine retraction on a round cross-section archwire

Canines will be retracted on an archwire with a diameter of 0.019 x 0.025-inch.

Traditional canine retraction on a rectangular-cross-section archwire

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged 18-25 years
  • Mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°),
  • A normal to slightly increased vertical growth pattern (Björk's sum \> 390° and \< 406°),
  • An overjet of 5-10 mm.
  • A further prerequisite was a camouflage treatment plan involving the extraction of the maxillary first premolars.

You may not qualify if:

  • the presence of no systemic health issues or any systemic condition known to influence the rate of orthodontic tooth movement,
  • active periodontal disease,
  • absence of any permanent teeth in the upper arch (excluding third molars),
  • crowding of 4 mm or greater,
  • inadequate oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

Location

Related Publications (5)

  • Mavreas D, Athanasiou AE. Factors affecting the duration of orthodontic treatment: a systematic review. Eur J Orthod. 2008 Aug;30(4):386-95. doi: 10.1093/ejo/cjn018.

    PMID: 18678758BACKGROUND
  • Al-Ibrahim HM, Hajeer MY, Burhan AS, Sultan K, Ajaj MA, Mahaini L. The Efficacy of Accelerating Orthodontic Tooth Movement by Combining Self-Ligating Brackets With One or More Acceleration Methods: A Systematic Review. Cureus. 2022 Dec 23;14(12):e32879. doi: 10.7759/cureus.32879. eCollection 2022 Dec.

    PMID: 36578856BACKGROUND
  • Kusy RP, Whitley JQ. Influence of archwire and bracket dimensions on sliding mechanics: derivations and determinations of the critical contact angles for binding. Eur J Orthod. 1999 Apr;21(2):199-208. doi: 10.1093/ejo/21.2.199.

    PMID: 10327744BACKGROUND
  • Southard TE, Marshall SD, Grosland NM. Friction does not increase anchorage loading. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):412-4. doi: 10.1016/j.ajodo.2006.09.037.

    PMID: 17346599BACKGROUND
  • Tidy DC. Frictional forces in fixed appliances. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):249-54. doi: 10.1016/0889-5406(89)90462-9.

    PMID: 2773871BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohammad N. Kheshfeh, DDS, MSc

    Department of Orthodontics, University of Damascus

    PRINCIPAL INVESTIGATOR
  • Mohammad Younis Hajeer, DDS, MSc, PhD

    Department of Orthodontics, University of Damascus

    STUDY CHAIR
  • Ahamd S. Burhan, DDS, MSc, PhD

    Department of Orthodontics, Unviersity of Damascus

    STUDY DIRECTOR

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

November 14, 2025

First Posted

November 24, 2025

Study Start

July 7, 2023

Primary Completion

April 1, 2024

Study Completion

July 15, 2024

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations