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Completed

NCT Number: NCT07243509

Evaluating the Efficacy of the Sliding Mechanisms on Round-section Arch Wire

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

About this study

In adult Class II camouflage treatment, the extraction of the first premolars is followed by a two-phase retraction protocol, consisting of initial canine retraction and subsequent incisor retraction, which is a standard approach. However, this process often extends treatment duration up to 36 months, creating significant clinical challenges. Prolonged orthodontic therapy not only burdens patients but also increases the risk of complications such as dental caries, root resorption, and periodontal problems, emphasizing the need for more efficient treatment strategies.

To accelerate tooth movement, both surgical and non-surgical methods have been explored. Surgical interventions, including corticotomy, piezocision, flapless cortico-alveolar perforations, and periodontal accelerated osteogenic orthodontics, have shown promising results but remain invasive and less acceptable to patients. Consequently, non-surgical alternatives have gained attention, including low-level laser therapy, electrical stimulation, platelet-rich plasma injections, and mechanical innovations such as self-ligating brackets. Despite these advances, canine retraction remains biomechanically demanding due to its slow rate and the difficulty of controlling unwanted rotation and angulation.

Mechanically, rectangular archwires provide torque control but generate high friction at the bracket-wire interface, delaying canine movement. Round-section archwires, by contrast, reduce bracket-wall contact and friction, enabling smoother sliding mechanics, improved angulation control, and reduced anchorage strain. Despite these theoretical advantages, clinical evidence is scarce. The only notable study, by Hamid, was limited by methodological shortcomings, including a short four-week observation period and a lack of long-term data. Importantly, no clinical trial has systematically evaluated sliding mechanics using a 0.020-inch round archwire, leaving a critical gap in the literature.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Round-cross-section archwire

Procedure

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

Rectangular-cross-section archwire

Procedure

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

Primary outcomes

  1. Change in the Rate of Maxillary Canine Retraction

    Time frame: 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)

    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.

Secondary outcomes

  1. Change in Canine Rotation

    Time frame: 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)

    Canine rotation is defined as the angle between the mid-palatal plane and the line connecting the mesial and distal ridges of the canine crown. The angular shift between consecutive intervals is divided by the interval duration to yield monthly rotation rates. Per-subject averages for right and left canines are computed and then averaged across participants.

  2. Change in Anchorage Loss

    Time frame: 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)

    Anchorage loss is assessed by measuring first-molar movement relative to the third palatal ruga. Linear distances between the maxillary first molar fossa and the medial end of the third palatal ruga, both projected onto the mid-palatal plane, are recorded at T0-TF. Monthly drift rates are calculated similarly to canine retraction, averaged per side, and then across the cohort.

  3. Change in Canine Angulation

    Time frame: 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)

    Canine angulation change is evaluated at T0 and TF via standardized lateral cephalograms. To enhance measurement accuracy, stainless-steel reference wires (0.021 × 0.025 mm; 12 mm apical extension) are affixed to each canine: circular-ended on the right, triangular-ended on the left. Radiographs are analyzed in ImageJ (NIH, USA). Angulation is defined as the angle between each wire and the Sella-Nasion plane.

  4. Root Resorption of the Canine

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

    External apical root resorption (EARR) is assessed by comparing maxillary canine root lengths on panoramic radiographs taken at T0 and TF. Baseline root length is recorded at T0; at TF, the reduction in length is measured, and the percentage of resorption is calculated. All measurements are performed in ImageJ (National Institutes of Health, Bethesda, Maryland, USA).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficacy of Sliding Mechanisms on Round Versus Rectangular Archwires in Canine Retraction After First Premolar Extraction in Class II Malocclusion: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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