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Efficiency of Canine Retraction Using Different Reactivation Intervals

Primary Purpose

Class II Division 1 Malocclusion, Class III Malocclusion, Bimaxillary Protrusion

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Canine retraction
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Future University in EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

2-week reactivation interval

4-week reactivation interval

6-week reactivation interval

8-week reactivation interval

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Amount of canine retraction
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
Canine tipping
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.
Canine rotation
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
Canine root resorption
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
First molar anchorage loss
The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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
Pain score
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

Full Information

First Posted
May 23, 2021
Last Updated
May 23, 2021
Sponsor
Future University in Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04905004
Brief Title
Efficiency of Canine Retraction Using Different Reactivation Intervals
Official Title
Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion, Class III Malocclusion, Bimaxillary Protrusion, Crowding, Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-week reactivation interval
Arm Type
Experimental
Arm Description
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
Arm Title
4-week reactivation interval
Arm Type
Active Comparator
Arm Description
Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force
Arm Title
6-week reactivation interval
Arm Type
Experimental
Arm Description
Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force
Arm Title
8-week reactivation interval
Arm Type
Experimental
Arm Description
Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force
Intervention Type
Procedure
Intervention Name(s)
Canine retraction
Intervention Description
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
Primary Outcome Measure Information:
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
Baseline to 1 month
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
1month to 2 months
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
2 months to 3 months
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
3 months to 4 months
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
4 months to 5 months
Title
Rate of canine retraction
Description
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Time Frame
5 months to 6 months.
Secondary Outcome Measure Information:
Title
Amount of canine retraction
Description
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
Time Frame
Baseline to 6 months
Title
Canine tipping
Description
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.
Time Frame
Baseline to 6 months
Title
Canine rotation
Description
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
Time Frame
Baseline to 6 months
Title
Canine root resorption
Description
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
Time Frame
Baseline to 6 months
Title
First molar anchorage loss
Description
The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT
Time Frame
Baseline to 6 months
Title
Pain score
Description
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
Time Frame
baseline to day 1
Title
Pain score
Description
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
Time Frame
Baseline to day 2
Title
Pain score
Description
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
Time Frame
Baseline to day 3
Title
Pain score
Description
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
Time Frame
Baseline to day 4
Title
Pain score
Description
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
Time Frame
Baseline to day 5
Title
Pain score
Description
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
Time Frame
Baseline to day 6
Title
Pain score
Description
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
Time Frame
Baseline to day 7
Title
Pain score
Description
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
Time Frame
Baseline to day 8
Title
Pain score
Description
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
Time Frame
Baseline to day 9
Title
Pain score
Description
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
Time Frame
Baseline to day 10.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem ElShazly, MSc
Phone
+201114666516
Email
reemhazem24@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rudayna El-Badawy, MSc
Phone
+201159218899
Email
rudaynaelbadawy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehya Mostafa, PhD
Organizational Affiliation
Future University in Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Future University in Egypt
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehya Mostafa, PhD
Email
yehya3d@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Canine Retraction Using Different Reactivation Intervals

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