Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm

April 3, 2024 updated by: Anas Kassas, Mansoura University

Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm: A Split-Mouth Randomized Controlled Trial

Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.

Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction.

Study Overview

Detailed Description

Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Participant and eligibility criteria:

Twenty patients will be recruited from the Department of Orthodontics at Mansoura University Pre-treatment records will be taken including: Intraoral and extraoral photographs, panoramic radiographs, cephalometric radiographs, and study models.

Intervention:

Written and informed consents will be taken from the patients. All patients will start the treatment by bonding fixed appliance (preadjusted edgewise, 0.018-in. slot, Roth prescription). Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment will be performed until reaching 0.017×0.025-in. nickel titanium arch wire. After 4 weeks of using the 0.017×0.025 arch wire, canine retraction phase will be initiated on 0.016×0.022 stainless steel arch wire.

After leveling and alignment, mini-implants will be inserted interradicular between the upper second premolar and upper first molar on each side. The mini-implant will be ligated to upper second premolar for indirect anchorage. The first premolars will be extracted at the same day of mini-implant placement.

Canine retraction will start in the same day of upper first premolar extraction. A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm on one side, while direct retraction from the bracket will be used on the contralateral side. The retraction force will be adjusted to 150g using force gauge.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mansoura, Egypt
        • Faculty of Dentistry Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Class II div 1 patients with age range between 14 to 25 years
  • patients indicated for maxillary first premolar extraction
  • increased over jet
  • mild or no crowding in maxilla
  • no previous orthodontic treatment
  • no history of periodontal disease or bone loss
  • good oral hygiene
  • no systemic disease
  • absence of canine morphological abnormalities.

Exclusion Criteria:

  • patients not indicated for maxillary first premolar extraction
  • decreased or no over jet
  • moderate or severe crowding in maxilla
  • previous orthodontic treatment
  • history of periodontal disease or bone loss
  • bad oral hygiene
  • systemic disease
  • canine morphological abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: power arm canine retraction
A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm will be used for canine retraction.
Experimental: canine retraction without power arm
A nickel titanium closed coil spring will be stretched from the mini-implant to the canine bracket will be used for canine retraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canine tipping
Time Frame: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.

The change in the mesiodistal crown angulation of the canine will be calculated at each time point.

4 months
Canine mobility
Time Frame: 4 months
The Periotest device will be used to measure the mobility of the canine immediately before retraction and repeated monthly for 4 months.
4 months
Implant stability
Time Frame: 4 months
The Periotest device will be used to measure the stability of the mini-implant immediately before retraction and repeated monthly for 4 months.
4 months
Pain assessment
Time Frame: 1 week

Pain assessment will be recorded by the visual analog scale (VAS) form. The participants will be informed to accomplish a visual analog scale diary containing 4 different times: four hours, 24 hours, 72 hours, and one week, following the beginning of the canine retraction.

The pain level was on the 10-cm (100-mm) visual analog scale forms, with 0 (minimum) denoting no pain, while 100 (maximum) denoting sever pain.

1 week
canine rotation
Time Frame: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.

The change in rotation of the canine will be calculated at each time point.

4 months
canine retraction rate
Time Frame: 4 months

Intraoral scanning for maxillary arch will be recorded every month for each patient; at T0 (Immediately before canine retraction), T1 (after 1 month), T2 (2 months), T3 (3 months) and T4 (4 months). The four obtained digital models from each patient will be separately superimposed on each other.

The retraction rate will be analyzed monthly and the total amount of canine retraction rate will be measured from cusp tip of the canine T0 to the same point in T4 for both sides.

4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Actual)

March 9, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Dentist Anas Kassas

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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