- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905004
Efficiency of Canine Retraction Using Different Reactivation Intervals
May 23, 2021 updated by: Yehya Mostafa, Future University in Egypt
Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
56
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 Contact
- Name: Reem ElShazly, MSc
- Phone Number: +201114666516
- Email: reemhazem24@gmail.com
Study Contact Backup
- Name: Rudayna El-Badawy, MSc
- Phone Number: +201159218899
- Email: rudaynaelbadawy@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 11865
- Recruiting
- Future University in Egypt
-
Contact:
- Yehya Mostafa, PhD
- Email: yehya3d@gmail.com
-
-
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
13 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: 2-week reactivation interval
Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force
|
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
|
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
|
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
|
Canines will be retracted using short elastomeric chains.
Force applied to canines will be 150g.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of canine retraction
Time Frame: 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.
|
Baseline to 1 month
|
Rate of canine retraction
Time Frame: 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.
|
1month to 2 months
|
Rate of canine retraction
Time Frame: 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.
|
2 months to 3 months
|
Rate of canine retraction
Time Frame: 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.
|
3 months to 4 months
|
Rate of canine retraction
Time Frame: 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.
|
4 months to 5 months
|
Rate of canine retraction
Time Frame: 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.
|
5 months to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of canine retraction
Time Frame: Baseline to 6 months
|
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
|
Baseline to 6 months
|
Canine tipping
Time Frame: 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.
|
Baseline to 6 months
|
Canine rotation
Time Frame: 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
|
Baseline to 6 months
|
Canine root resorption
Time Frame: Baseline to 6 months
|
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
|
Baseline to 6 months
|
First molar anchorage loss
Time Frame: 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
|
Baseline to 6 months
|
Pain score
Time Frame: 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
|
baseline to day 1
|
Pain score
Time Frame: 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
|
Baseline to day 2
|
Pain score
Time Frame: 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
|
Baseline to day 3
|
Pain score
Time Frame: 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
|
Baseline to day 4
|
Pain score
Time Frame: 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
|
Baseline to day 5
|
Pain score
Time Frame: 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
|
Baseline to day 6
|
Pain score
Time Frame: 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
|
Baseline to day 7
|
Pain score
Time Frame: 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
|
Baseline to day 8
|
Pain score
Time Frame: 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
|
Baseline to day 9
|
Pain score
Time Frame: 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
|
Baseline to day 10.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yehya Mostafa, PhD, Future University in Egypt
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)
April 1, 2017
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
May 23, 2021
First Submitted That Met QC Criteria
May 23, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Actual)
May 27, 2021
Last Update Submitted That Met QC Criteria
May 23, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Malocclusion
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- 20153110-8-14-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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