Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes

NCT07688655 | Completed DMC

• 1 other identifier: UDDS-2026-Ortho-5
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion; Displaced Teeth; Malocclusion of Anterior Teeth

Keywords

Archwire sequence protocol; Volumetric external root resorption; Alveolar bone changes; Buccal alveolar bone height; Buccal alveolar bone thickness; Cone-beam computed tomography

Outcome Measures

Primary Outcomes (1)

• 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).

  Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.

Secondary Outcomes (4)

• Buccal Alveolar Bone Height Change (DBH)

  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)

  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)

  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)

  Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.

Study Arms (3)

Square-shaped cross-sectional archwire group

EXPERIMENTAL

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

Rectangular-shaped cross-sectional archwire group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Square-shaped cross-sectional archwire PROCEDURE

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.

Square-shaped cross-sectional archwire group

Rectangular-shaped cross-sectional archwire PROCEDURE

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.

Rectangular-shaped cross-sectional archwire group

Traditional sequence of archwires PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

Location

Related Publications (6)

• 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.

  PMID: 16027626 BACKGROUND

• 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.

  PMID: 26780465 BACKGROUND

• 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.

  PMID: 26718381 BACKGROUND

• 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.

  PMID: 38319008 BACKGROUND

• 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.

  PMID: 24351147 BACKGROUND

• 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.

  PMID: 24763679 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Waseem M Allouch, DDS, MSc

  Faculty of Dentistry, University of Damascus.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 7, 2026
• Study Start: March 3, 2024
• Primary Completion: June 16, 2025
• Study Completion: December 25, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)