ClinicalTrials.gg
Status unknownNCT04905004Updated May 27, 2021

Efficiency of Canine Retraction Using Different Reactivation Intervals

An interventional study of Canine retraction in Class II Division 1 Malocclusion, Class III Malocclusion and Bimaxillary Protrusion, sponsored by Future University in Egypt. Status unknown at 1 site in Egypt. Open to participants aged 13 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Apr 2017, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
13 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Class II Division 1 Malocclusion
  • Class III Malocclusion
  • Bimaxillary Protrusion
  • Crowding, Tooth
03

In context

Malocclusion, Angle Class II

124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.

This study's planned enrollment of 56 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.

Browse Malocclusion, Angle Class II studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
  • Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    2-week reactivation interval

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

    Procedure: Canine retraction

  • Active comparator
    4-week reactivation interval

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

    Procedure: Canine retraction

  • Experimental
    6-week reactivation interval

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

    Procedure: Canine retraction

  • Experimental
    8-week reactivation interval

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

    Procedure: Canine retraction

Interventions

  • ProcedureCanine retraction

    Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 1 month

  2. 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.

    Time frame: 1month to 2 months

  3. 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.

    Time frame: 2 months to 3 months

  4. 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.

    Time frame: 3 months to 4 months

  5. 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.

    Time frame: 4 months to 5 months

  6. 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.

    Time frame: 5 months to 6 months.

Secondary outcomes

  1. Amount of canine retraction

    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

  2. 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.

    Time frame: Baseline to 6 months

  3. 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

    Time frame: Baseline to 6 months

  4. Canine root resorption

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

    Time frame: Baseline to 6 months

  5. 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

    Time frame: Baseline to 6 months

  6. 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

    Time frame: baseline to day 1

  7. 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

    Time frame: Baseline to day 2

  8. 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

    Time frame: Baseline to day 3

  9. 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

    Time frame: Baseline to day 4

  10. 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

    Time frame: Baseline to day 5

  11. 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

    Time frame: Baseline to day 6

  12. 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

    Time frame: Baseline to day 7

  13. 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

    Time frame: Baseline to day 8

  14. 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

    Time frame: Baseline to day 9

  15. 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

    Time frame: Baseline to day 10.

07

Study locations

1 of 1 sites recruiting
  • Future University in Egypt
    Cairo, 11865, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2017 (actual). Primary completion is estimated for Jun 2022, 62 months after the start.

Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's planned 62 months is above that.

Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2021
First posted
May 27, 2021
StartActual
Apr 1, 2017
Primary completionEst.
Jun 1, 2022
CompletionEst.
Jun 1, 2022
Last update
May 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04905004
Responsible party
Yehya Mostafa (Head of the Orthodontics Department, Future University in Egypt) — Principal investigator
First posted
May 27, 2021
Start date
Apr 1, 2017
Primary completion
Jun 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
May 27, 2021

Study contacts

Reem ElShazly, MSc
Contact
reemhazem24@gmail.com
+201114666516
Rudayna El-Badawy, MSc
Contact
rudaynaelbadawy@gmail.com
+201159218899
Yehya Mostafa, PhD
study director · Future University in Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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