NCT04905004

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

5.2 years

First QC Date

May 23, 2021

Last Update Submit

May 23, 2021

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline to 1 month

  • 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.

    1month to 2 months

  • 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.

    2 months to 3 months

  • 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.

    3 months to 4 months

  • 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.

    4 months to 5 months

  • 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.

    5 months to 6 months.

Secondary Outcomes (15)

  • Amount of canine retraction

    Baseline to 6 months

  • Canine tipping

    Baseline to 6 months

  • Canine rotation

    Baseline to 6 months

  • Canine root resorption

    Baseline to 6 months

  • First molar anchorage loss

    Baseline to 6 months

  • +10 more secondary outcomes

Study Arms (4)

2-week reactivation interval

EXPERIMENTAL

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

Procedure: Canine retraction

4-week reactivation interval

ACTIVE COMPARATOR

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

Procedure: Canine retraction

6-week reactivation interval

EXPERIMENTAL

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

Procedure: Canine retraction

8-week reactivation interval

EXPERIMENTAL

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

Procedure: Canine retraction

Interventions

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

2-week reactivation interval4-week reactivation interval6-week reactivation interval8-week reactivation interval

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University in Egypt

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class IIMalocclusion, Angle Class IIIMalocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Yehya Mostafa, PhD

    Future University in Egypt

    STUDY DIRECTOR

Central Study Contacts

Reem ElShazly, MSc

CONTACT

Rudayna El-Badawy, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Orthodontics Department

Study Record Dates

First Submitted

May 23, 2021

First Posted

May 27, 2021

Study Start

April 1, 2017

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations