Comparison of the Efficiency of Maxillary Canine Retraction Using Aligners Versus Conventional Brackets in Orthodontic Extraction Cases.

April 2, 2020 updated by: Amr Mostafa Osman Ramadan, Cairo University
The aim of this study is to compare the effectiveness of Clear aligners and Conventional braces for upper canine retraction (space closure) regarding canine tipping , anchorage loss and treatment time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Conventional fixed orthodontic treatment with metal brackets has been rejected by some adult patients because of esthetic and social concerns, but the demand for orthodontic treatment is currently increasing. To satisfy the demands and needs of these patients, the emphasis has shifted toward esthetic orthodontic appliance system. Less noticeable appliances such as ceramic, resin, and lingual brackets, or removable clear appliances such as the Essix and Invisalign (Align Technology, Santa Clara, Calif) provide esthetic orthodontic appliance alternatives.

Since the introduction of clear aligners to the public in 1999, it has become a popular treatment choice for clinicians because of the aesthetics and comfort of the removable clear aligners compared with traditional appliances. Several studies have shown significant limitations of this technique, especially in treating complex malocclusions, whereas other studies have reported successfully treated cases with this removable appliance. A systematic review conducted to determine the treatment effects of clear aligners showed that no strong conclusions could be made regarding the treatment effects of aligners . Therefore, clinical trials were still required to investigate the effectiveness of the Invisalign system.

When using the aligners to correct severe crowding, root positions must be carefully controlled during extraction space closure, and clear aligners must be properly grip all teeth to be moved, Tipping was a common problem in premolar extraction cases during the early years of aligners use. Several previous reports have also discussed the limited ability of thermoplastic appliances to control root-tipping movements and to establish root control comparable to that provided by fixed appliances. The investigators describe the extraction treatment of a patient with moderate to severe tooth crowding using mini screws and clear appliances, thus eliminating the need for conventional brackets.

Study Type

Interventional

Enrollment (Anticipated)

10

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 Locations

  • Egypt
      • Cairo, Egypt, 11553
        • Amr Mostafa Osman Ramadan
        • Contact:
          • Amr Ramadan, Master 's of orthodontics
          • Phone Number: 0020106801410

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

16 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Moderate to severe crowding orthodontic patients.( Irregularity index of <5 mm)

    2) Good oral hygiene. (Patient with periodontally sound dentition).

    3) Patient in permanent dentition between the age range 16 - 40 years.

    4) .Patients requiring extraction of mandibular and maxillary first premolars;

    5) Patients having sound general health

Exclusion Criteria:

  • 1) Systematic disease.

    2) Poor oral hygiene patients.

    3 ) Periodontally affected teeth.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aligners group
Receiving full set of aligners ( Clear Removable Orthodontic appliance) until complete canine retraction
Device: Removable Clear Aligners
  1. Plaster dental models will be poured from the rubber base impression.
  2. Digital dental models will be created through scanning of plaster dental models.
  3. Planning of the aligners will be done on 3 shape clear aligner studio®.
  4. Aligners will be fabricated on 3d printed models using vacuum formers.
  5. Anchorage reinforcement for posterior segments by using buccal miniscrews.
  6. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
  7. Patient will receive the following aligner after 2 weeks.
  8. Follow up visits every 2 weeks until complete canine retraction.
ACTIVE_COMPARATOR: Conventional Brackets group
leveling and alignment of lower followed by complete canine retraction
Device: Removable Clear Aligners
  1. Plaster dental models will be poured from the rubber base impression.
  2. Digital dental models will be created through scanning of plaster dental models.
  3. Planning of the aligners will be done on 3 shape clear aligner studio®.
  4. Aligners will be fabricated on 3d printed models using vacuum formers.
  5. Anchorage reinforcement for posterior segments by using buccal miniscrews.
  6. Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
  7. Patient will receive the following aligner after 2 weeks.
  8. Follow up visits every 2 weeks until complete canine retraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canine Retraction (Space Closure )
Time Frame: 6 months
measured in millimeters
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canine Tipping
Time Frame: 6 months
it will be assessed by Angle degrees
6 months
Anchorage loss
Time Frame: 6 months
it will be assessed by Angle degrees
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

July 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (ACTUAL)

April 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Aligners in Canine Retraction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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