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

NCT ID: NCT07243509

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-07

Study Completion Date

2024-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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CLASS II DIVISION 1 MALOCCLUSION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Canine retraction on a round cross-section archwire

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

Group Type EXPERIMENTAL

Round-cross-section archwire

Intervention Type PROCEDURE

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

Traditional canine retraction on a rectangular-cross-section archwire

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

Group Type ACTIVE_COMPARATOR

Rectangular-cross-section archwire

Intervention Type PROCEDURE

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

Interventions

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Round-cross-section archwire

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

Intervention Type PROCEDURE

Rectangular-cross-section archwire

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad N. Kheshfeh, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, University of Damascus

Mohammad Younis Hajeer, DDS, MSc, PhD

Role: STUDY_CHAIR

Department of Orthodontics, University of Damascus

Ahamd S. Burhan, DDS, MSc, PhD

Role: STUDY_DIRECTOR

Department of Orthodontics, Unviersity of Damascus

Locations

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Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 18678758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36578856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10327744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17346599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2773871 (View on PubMed)

Other Identifiers

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UDDS-2025-Ortho-10

Identifier Type: -

Identifier Source: org_study_id

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