Comparing Ligation Methods During Canine Retraction Stage Using Conventional Brackets

NCT07063186 | Not Yet Recruiting

• 1 other identifier: IIUM_LigationStudy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Randomized Controlled Trial (RCT) is to determine the most effective way to tie the main wire to the regular orthodontic brackets during the stage of orthodontic treatment where the canines are retracted. This study is for orthodontic patients aged 16 years and older who need to have their canines retracted into spaces where other teeth have been removed. The main questions it aims to answer are:

• Group A: Uses an elastic power chain that wraps around all four parts (wings) of the brace.
• Group B: Uses thin stainless-steel wires (ligatures) to tie the brace first, then an elastic power chain is placed over these wires, also wrapping around all four parts of the brace.
• Group C: Uses small elastic rings on the two front parts (mesial wings) of the brace, and an elastic power chain on the two back parts (distal wings) of the brace. Participants will consist of orthodontic patients aged 16 years and above from the Postgraduate Orthodontic Clinic, Kulliyyah of Dentistry, IIUM, Kuantan, who require extraction of one or both maxillary first premolars, are planned for maximum anchorage using a Nance appliance, need at least 4mm of maxillary canine retraction, and have good oral hygiene. Participants will:
• Undergo screening and provide written informed consent for participation.
• Receive a comprehensive orthodontic examination, including photographic records, impressions, and radiographs.
• Have molar bands fitted and a Nance button fabricated and cemented, followed by dental extractions of maxillary first premolars.
• Undergo bond-up with conventional stainless-steel brackets and initial archwire placement.
• Progress through an alignment and levelling phase using progressively larger archwires, culminating in a 0.019 x 0.025-inch stainless steel archwire.
• At baseline (T0) and subsequent 4-week follow-up intervals (T1, T2, T3), have intraoral three-dimensional scans taken after archwire removal.
• Receive canine retraction using elastomeric power chains delivering a standardized 150g force. This is done as a two-step retraction, where the canine is retracted in isolation.
• Continue to receive full orthodontic treatment to completion even after the data collection period ends at T3.

Conditions

Malocclusion; Canine Retraction

Keywords

Ligation Methods; Canine Retraction; Conventional Brackets; 3D Superimposition; Two-step Retraction; Anchorage Loss; Three-dimensional Positional Change; Canine Rotation; Canine Tipping; Canine Extrusion; Intraoral Scanners

Outcome Measures

Primary Outcomes (1)

• Amount of canine retraction (millimetres /mm)

  The linear distance (mm) that the maxillary canine has moved distally from baseline (T0) to subsequent intervals will be measured

  12 weeks

Secondary Outcomes (4)

• Canine Rotation

  12 weeks

• Canine Tipping

  12 weeks

• Canine Extrusion

  12 weeks

• Anchorage Loss (mm)

  12 weeks

Study Arms (3)

Group A - Elastomeric power chain on all bracket wings

EXPERIMENTAL

This group uses an elastomeric power chain engaged on all bracket wings

Other: Group A - Elastomeric power chain on all bracket wings.

Group B - Stainless steel ligatures with elastomeric power chain placed over all bracket wings

EXPERIMENTAL

This group involves stainless steel ligatures used to tie in the archwire on all bracket wings, with an elastomeric power chain placed over the ligatures and engaging all four bracket wings of the maxillary canine

Other: Group B - Stainless steel ligatures with elastomeric power chain placed over all bracket wings.

Group C - Elastomeric modules on mesial wings and power chain on distal wings

EXPERIMENTAL

In this group, elastomeric modules are placed on the mesial wings, and an elastomeric power chain is engaged on the distal wings of the maxillary canine bracket

Other: Group C - Elastomeric modules on mesial wings and power chain on distal wings.

Interventions

Group A - Elastomeric power chain on all bracket wings. OTHER

Elastomeric power chain is engaged on all bracket wings

Group A - Elastomeric power chain on all bracket wings

Group B - Stainless steel ligatures with elastomeric power chain placed over all bracket wings. OTHER

Stainless steel ligatures are used to tie in the archwire on all bracket wings, with an elastomeric power chain placed over the ligatures

Group B - Stainless steel ligatures with elastomeric power chain placed over all bracket wings

Group C - Elastomeric modules on mesial wings and power chain on distal wings. OTHER

Elastomeric modules are placed on the mesial wings of each bracket, while an elastomeric power chain is engaged on the distal wings

Group C - Elastomeric modules on mesial wings and power chain on distal wings

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 16 years and above.
• Patients who require extraction of one or both maxillary first premolars as part of their orthodontic treatment.
• Patient who are planned for maximum anchorage using Nance appliance.
• Patients who require at least 4mm of maxillary canine retraction as part of their orthodontic treatment.
• Patients with good oral hygiene.

You may not qualify if:

• Patients with craniofacial anomalies.
• Patients with systemic or bone diseases that could affect tooth movement (e.g., osteopetrosis, osteogenesis imperfecta, Paget's disease).
• Patients on medications that may affect tooth movement.
• Patients with hypodontia.
• Patients with poor dental health where orthodontic treatment is not feasible.

Sponsors & Collaborators

• International Islamic University Malaysia: lead

Study Sites (1)

International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (11)

• Cha BK, Lee JY, Jost-Brinkmann PG, Yoshida N. Analysis of tooth movement in extraction cases using three-dimensional reverse engineering technology. Eur J Orthod. 2007 Aug;29(4):325-31. doi: 10.1093/ejo/cjm019. Epub 2007 May 19.

  PMID: 17513876 BACKGROUND

• Cattaneo PM, Tepedino M, Hansen EB, Gram AR, Cornelis MA. Operating time for wire ligation with self-ligating and conventional brackets: A standardized in vitro study. Clin Exp Dent Res. 2022 Dec;8(6):1456-1466. doi: 10.1002/cre2.642. Epub 2022 Aug 26.

  PMID: 36017763 BACKGROUND

• Bian C, Lyu M, Zhu M, Liu M, Xie X, Weir MD, Hack GD, Masri R, Zhang K, Bai Y, Xu HHK, Zhang N. Novel antibacterial orthodontic elastomeric ligature with oral biofilm-regulatory ability to prevent enamel demineralization. Dent Mater. 2024 Oct;40(10):1534-1545. doi: 10.1016/j.dental.2024.07.015. Epub 2024 Jul 26.

  PMID: 39060129 BACKGROUND

• Baxi S, Tripathi AA, Bhatia V, Prasad Dubey M, Kumar P, Bagde H. Self-Ligating Bracket Systems: A Comprehensive Review. Cureus. 2023 Sep 7;15(9):e44834. doi: 10.7759/cureus.44834. eCollection 2023 Sep.

  PMID: 37809259 BACKGROUND

• Badran SA, Al-Zaben JM, Al-Taie LM, Tbeishi H, Al-Omiri MK. Comparing patient-centered outcomes and efficiency of space closure between nickel-titanium closed-coil springs and elastomeric power chains during orthodontic treatment. Angle Orthod. 2022 Jul 1;92(4):471-477. doi: 10.2319/120721-906.

  PMID: 35348615 BACKGROUND

• Alrehaili R, Alhujaili A, Almanjhi W, Alnami H, Alsaiyari S, Alqahtani H, Alabdan R, Baamer D, Khalil A. How Effective Are the Nance Appliance and Transpalatal Arch at Reinforcing Anchorage in Extraction Cases? Cureus. 2024 May 27;16(5):e61171. doi: 10.7759/cureus.61171. eCollection 2024 May.

  PMID: 38933638 BACKGROUND

• Al-Haifi HAA, Ishaq RAA, Al-Hammadi MSA. Salivary pH changes under the effect of stainless steel versus elastomeric ligatures in fixed orthodontic patients: a single-center, randomized controlled clinical trial. BMC Oral Health. 2021 Oct 22;21(1):544. doi: 10.1186/s12903-021-01906-4.

  PMID: 34686168 BACKGROUND

• Al-A'athal HS, Al-Nimri K, Alhammadi MS. Analysis of canine retraction and anchorage loss in different facial types with and without piezocision: a split-mouth-design, randomized clinical trial. Angle Orthod. 2022 Nov 1;92(6):746-754. doi: 10.2319/111921-853.1.

  PMID: 35852456 BACKGROUND

• Al Fakir H, Carey JP, Melenka GW, Nobes DS, Heo G, Major PW. Investigation into the effects of stainless steel ligature ties on the mechanical characteristics of conventional and self-ligated brackets subjected to torque. J Orthod. 2014 Sep;41(3):188-200. doi: 10.1179/1465313314Y.0000000096. Epub 2014 Mar 4.

  PMID: 24596162 BACKGROUND

• Abu Alhaija ES, Al Shayeb RA, Al-Khateeb S, Daher HO, Daher SO. A comparative assessment of the amount and rate of orthodontic space closure toward a healed vs recent lower premolar extraction site. Angle Orthod. 2022 Jul 1;92(4):463-470. doi: 10.2319/102921-797.1.

  PMID: 35344007 BACKGROUND

• Abd ElMotaleb MA, El-Beialy AR, El-Sharaby FA, ElDakroury AE, Eid AA. Effectiveness of low frequency vibration on the rate of canine retraction: a randomized controlled clinical trial. Sci Rep. 2024 Apr 4;14(1):7952. doi: 10.1038/s41598-024-58268-4.

  PMID: 38575623 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Asst. Prof. Dr. Kumeran S/O Mohan

  International Islamic University Malaysia

  STUDY CHAIR

Central Study Contacts

SIVAM RAMASAMY

CONTACT

+60175347534; sivam12188@gmail.com

Asst. Prof. Dr. Kumeran S/O Mohan

CONTACT

+60164478057; kumeran@iium.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Orthodontic Resident

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)