An interventional study of Round-cross-section archwire and Rectangular-cross-section archwire in CLASS II DIVISION 1 MALOCCLUSION, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 38 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
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
Canines will be retracted on an archwire with a diameter of 0.20 inches.
Canines will be retracted on an archwire with a diameter of 0.019 x 0.025-inch.
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.
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)
Change in Canine Rotation
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.
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)
Change in Anchorage Loss
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.
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)
Change in Canine Angulation
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.
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)
Root Resorption of the Canine
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).
Time frame: T0: T0: 10 minutes before starting canine retraction stage; TF: At completion of canine retraction (expected to happen within 3 - 5 months)
Plan to share: No
Ran from Jul 2023 to primary completion in Apr 2024, 8 months.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 8 months is below that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class II →