Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases

September 25, 2019 updated by: Seif-Allah Ahmed Sherif Nasr, Cairo University
Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

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

18 years to 33 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged (18~33)
  • CVMI = 6
  • Moderate crowding (4-8) as described by Laura mitchel
  • No extractions required

Exclusion Criteria:

  • Growing patients
  • Previous orthodontic treatment
  • Missing teeth other than the wisdoms

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: control group
changing the archwire every 4 weeks
ACTIVE_COMPARATOR: intervention group
changing the archwire after 6 weeks instead of 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of alignment of teeth
Time Frame: 5 months
the teeth are aligned together by using Little irregularity index to measure the decrease in the discrepency in each digital model taken after changing of the wire
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

September 4, 2021

Study Completion (ANTICIPATED)

November 9, 2021

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ORTH 3-3-4

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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