NCT07063186

Comparing Ligation Methods During Canine Retraction Stage Using Conventional Brackets

Not yet recruiting NA Last updated 16 July 2025

What this trial tests

NA trial testing Group A - Elastomeric power chain on all bracket wings. in Malocclusion in 60 participants. Not yet recruiting.

Timeline

1 November 2025

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	International Islamic University Malaysia
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	1 November 2025
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across Malaysia

Drugs / interventions tested

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

Conditions studied

• Malocclusion — all drugs for Malocclusion →
• Canine Retraction — all drugs for Canine Retraction →

Sponsor

International Islamic University Malaysia

Who can join

16 and older, any sex, with Malocclusion or Canine Retraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. What is the effect of different ways of tying the wire to the braces on how much the maxillary canine moves back using conventional brackets?
2. How do various ways of tying the wire influence unwanted movements of the maxillary canines-specifically rotation, tipping, and extrusion?
3. What is the effect of these different tying methods on how much the back molar teeth shift forward (this is called "anchorage loss") while the maxillary canine is being pulled back?

Researchers will compare three different ways of tying the wire to the braces to see if they differ in the amount of maxillary canine retraction, three-dimensional positional changes (rotation, tipping, and extrusion), and anchorage loss of maxillary first molars:

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.