Efficiency of Canine Retraction Using Different Reactivation Intervals

Sponsor
Future University in Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT04905004
Collaborator
(none)
56
1
4
62
0.9

Study Details

Study Description

Brief Summary

Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Canine retraction
N/A

Detailed Description

The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
Actual Study Start Date :
Apr 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2-week reactivation interval

Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force

Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Active Comparator: 4-week reactivation interval

Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force

Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Experimental: 6-week reactivation interval

Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force

Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Experimental: 8-week reactivation interval

Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force

Procedure: Canine retraction
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

Outcome Measures

Primary Outcome Measures

  1. Rate of canine retraction [Baseline to 1 month]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

  2. Rate of canine retraction [1month to 2 months]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

  3. Rate of canine retraction [2 months to 3 months]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

  4. Rate of canine retraction [3 months to 4 months]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

  5. Rate of canine retraction [4 months to 5 months]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

  6. Rate of canine retraction [5 months to 6 months.]

    The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.

Secondary Outcome Measures

  1. Amount of canine retraction [Baseline to 6 months]

    The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT

  2. Canine tipping [Baseline to 6 months]

    CBCT images at T0 and T1 were analyzed using Invivo 5 software. linear measurements were made from the long axis of the canines (cusp tip to root apex) to FP1 and FP2 for the upper and lower canines, respectively.

  3. Canine rotation [Baseline to 6 months]

    The change in the angle between a line connecting the maximum mesial and distal crown convexities and FP1 and FP2, for the upper and lower canines, respectively; measured on CBCT

  4. Canine root resorption [Baseline to 6 months]

    The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT

  5. First molar anchorage loss [Baseline to 6 months]

    The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT

  6. Pain score [baseline to day 1]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  7. Pain score [Baseline to day 2]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  8. Pain score [Baseline to day 3]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  9. Pain score [Baseline to day 4]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  10. Pain score [Baseline to day 5]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  11. Pain score [Baseline to day 6]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  12. Pain score [Baseline to day 7]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  13. Pain score [Baseline to day 8]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  14. Pain score [Baseline to day 9]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

  15. Pain score [Baseline to day 10.]

    The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)

  • Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion Criteria:
  • Systemic diseases that would interfere with bone metabolism

  • Craniofacial syndromes

  • congenitally missing or extracted permanent teeth.

  • periodontally compromised patients

  • smokers

  • pregnant women

  • previous orthodontic treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Future University in Egypt Cairo Egypt 11865

Sponsors and Collaborators

  • Future University in Egypt

Investigators

  • Study Director: Yehya Mostafa, PhD, Future University in Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yehya Mostafa, Head of the Orthodontics Department, Future University in Egypt
ClinicalTrials.gov Identifier:
NCT04905004
Other Study ID Numbers:
  • 20153110-8-14-2017
First Posted:
May 27, 2021
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2021