Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes
Three-dimensional Evaluation of Volumetric Root Resorption and Alveolar Bone Changes Following Three Orthodontic Archwire Protocols: a Randomized Controlled Clinical Trial
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rif-dimashq Governorate
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Damascus, Rif-dimashq Governorate, Syria, DM20AM19
- Department of Orthodontics, Faculty of Dentistry, University of Damascus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 16 and 25 years
- Presence of a complete permanent dentition
- Moderate crowding ranging from 4 to 6 mm, according to Little's Irregularity Index (Little, 1975)
- Indication for non-extraction orthodontic treatment
- Normal or slightly retroclined incisors, as evaluated radiographically and on study models
- Good oral health status
- Periodontally healthy supporting tissues
Exclusion Criteria:
- Patients with severe skeletal discrepancies
- Patients with craniofacial anomalies
- Presence of impacted or supernumerary teeth
- History of previous orthodontic treatment
- Presence of systemic conditions or use of medications known to influence tooth movement
- Pregnant women
- Patients for whom the follow-up (T1) records were not obtained within the permitted 35-day window
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Square-shaped cross-sectional archwire group
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
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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.
|
|
Experimental: Rectangular-shaped cross-sectional archwire group
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
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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.
|
|
Active Comparator: Control group
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volumetric External Root Resorption (VERR)
Time Frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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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).
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Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Buccal Alveolar Bone Height Change (DBH)
Time Frame: Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
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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).
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Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
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Buccal Alveolar Bone Thickness Change at the Cervical Level (DBT-CT)
Time Frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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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).
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Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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Buccal Alveolar Bone Thickness Change at the Middle Level (DBT-MT)
Time Frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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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).
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Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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Buccal Alveolar Bone Thickness Change at the Apical Level (DBT-AT)
Time Frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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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).
|
Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waseem M Allouch, DDS, MSc, Faculty of Dentistry, University of Damascus.
Publications and helpful links
General Publications
- Montasser MA, Keilig L, Bourauel C. Archwire diameter effect on tooth alignment with different bracket-archwire combinations. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):76-83. doi: 10.1016/j.ajodo.2015.06.026.
- Gravina MA, Brunharo IH, Fraga MR, Artese F, Campos MJ, Vitral RW, Quintao CC. Clinical evaluation of dental alignment and leveling with three different types of orthodontic wires. Dental Press J Orthod. 2013 Nov-Dec;18(6):31-7. doi: 10.1590/s2176-94512013000600006.
- Smale I, Artun J, Behbehani F, Doppel D, van't Hof M, Kuijpers-Jagtman AM. Apical root resorption 6 months after initiation of fixed orthodontic appliance therapy. Am J Orthod Dentofacial Orthop. 2005 Jul;128(1):57-67. doi: 10.1016/j.ajodo.2003.12.030.
- Papageorgiou SN, Sifakakis I, Doulis I, Eliades T, Bourauel C. Torque efficiency of square and rectangular archwires into 0.018 and 0.022 in. conventional brackets. Prog Orthod. 2016;17:5. doi: 10.1186/s40510-016-0118-0. Epub 2016 Jan 15.
- Liu C, Wei Z, Jian F, McIntyre G, Millett DT, Lai W, Wang Y. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2024 Feb 6;2(2):CD007859. doi: 10.1002/14651858.CD007859.pub5.
- Ajmera S, Shivanand Venkatesh, Ganeshkar SV. Volumetric evaluation of root resorption during orthodontic treatment. J Clin Orthod. 2014 Feb;48(2):113-9. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-2026-Ortho-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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