An interventional study of Square-shaped cross-sectional archwire and Rectangular-shaped cross-sectional archwire in Malocclusion of Anterior Teeth and Malocclusion; Displaced Teeth, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial compares the effects of three orthodontic archwire protocols used during the alignment phase on anterior tooth roots and the supporting alveolar bone. Participants were randomly allocated to one of three parallel groups according to the experimental archwire used. Cone-beam computed tomography (CBCT) images were obtained before treatment initiation and after completion of the follow-up period. The primary outcome is volumetric root resorption, while secondary outcomes include changes in Buccal alveolar bone height and thickness. Recruitment and follow-up have been completed, and the study is currently in the data verification and statistical analysis phase. The findings are expected to help clinicians choose archwire protocols that reduce undesirable biological side effects during orthodontic treatment.
Orthodontic tooth movement may result in undesirable biological side effects, including external root resorption and remodeling of the alveolar bone surrounding the moved teeth. These effects are clinically important because they may influence long-term tooth support and treatment safety. During the alignment phase of orthodontic treatment, different archwire designs may produce different biomechanical effects; however, evidence comparing their influence on root structure and alveolar bone remains limited.
This study is a randomized controlled clinical trial designed to compare three orthodontic archwire protocols during the alignment phase in patients undergoing fixed orthodontic treatment. The primary objective is to assess volumetric root resorption in the anterior teeth using three-dimensional CBCT-based measurements. Secondary objectives include assessment of alveolar bone height change, and alveolar bone thickness change at standardized cervical, middle, and apical levels.
Participants were enrolled from the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible patients were randomly allocated to one of three parallel groups. All groups received the same initial alignment sequence using 0.014-inch nickel-titanium and 0.016-inch nickel-titanium archwires. The groups differed in the experimental archwire used thereafter. The square group received a 0.016 × 0.016-inch nickel-titanium archwire, the rectangular group received a 0.016 × 0.022-inch nickel-titanium archwire, and the control group continued with a 0.016-inch round nickel-titanium archwire. Archwire changes were performed at standardized 35-day intervals according to the study protocol.
CBCT records were obtained at baseline before treatment initiation and again at the end of the observation period. Root volume measurements were used to calculate volumetric root resorption in cubic millimeters and as a percentage of the baseline root volume. Buccal alveolar bone height and thickness were measured on standardized CBCT sections using predefined reference planes and anatomical landmarks.
Participant recruitment started on 01 October 2023, and follow-up of the last participant was completed on 25 June 2025. The study is currently in the data verification and statistical analysis phase.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's enrollment of 53 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
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Exclusion Criteria:
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.016-inch nickel-titanium archwire as the experimental archwire
Procedure: Square-shaped cross-sectional archwire
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.022-inch nickel-titanium archwire as the experimental archwire
Procedure: Rectangular-shaped cross-sectional archwire
Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016-inch round nickel-titanium archwire, which served as the control wire.
Procedure: Traditional sequence of archwires
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.016-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.022-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016-inch round NiTi, which served as the control archwire. Archwire change will be done at 35-day intervals.
Volumetric External Root Resorption (VERR)
Volumetric root resorption was assessed in the anterior teeth using cone-beam computed tomography (CBCT) and three-dimensional volumetric analysis. Root volume was measured at baseline and follow-up, and the difference between the two measurements was recorded as volumetric root resorption. The unit of measurement was cubic millimeters (mm³).
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Height Change (DBH)
Buccal alveolar bone height was measured as the vertical distance from a standardized horizontal reference plane to the most coronal point of the Buccal alveolar crest on CBCT images. The change between baseline and follow-up was recorded in millimeters (mm).
Time frame: Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Cervical Level (DBT-CT)
Buccal alveolar bone thickness at the cervical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Middle Level (DBT-MT)
Buccal alveolar bone thickness at the middle root level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Apical Level (DBT-AT)
Buccal alveolar bone thickness at the apical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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