Efficiency of Canine Retraction Using Different Reactivation Intervals

NCT ID: NCT04905004

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2-week reactivation interval

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

Group Type EXPERIMENTAL

Canine retraction

Intervention Type PROCEDURE

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

4-week reactivation interval

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

Group Type ACTIVE_COMPARATOR

Canine retraction

Intervention Type PROCEDURE

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

6-week reactivation interval

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

Group Type EXPERIMENTAL

Canine retraction

Intervention Type PROCEDURE

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

8-week reactivation interval

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

Group Type EXPERIMENTAL

Canine retraction

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Canine retraction

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yehya Mostafa

Head of the Orthodontics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yehya Mostafa, PhD

Role: STUDY_DIRECTOR

Future University in Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Future University in Egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reem ElShazly, MSc

Role: CONTACT

+201114666516

Rudayna El-Badawy, MSc

Role: CONTACT

+201159218899

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yehya Mostafa, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20153110-8-14-2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.