3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding

July 14, 2024 updated by: Haidy Fekry

Three-Dimensional Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding: A Randomized Clinical Trial

Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.

Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.

Study Type

Interventional

Enrollment (Actual)

20

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, 002
        • Al Azhar Universty
      • Zagazig, Egypt, 002
        • Haidy Fekry

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .

Exclusion Criteria:

Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clear aligner therapy
U lab aligners
Device: U lab aligners
Aligner group change the aligner every 10 days
Experimental: Fixed orthodontic treatment
Oromo bracket
Device: oramco bracket
changing orthodontic wire every one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of lower anterior crowding
Time Frame: 6 months
according to little irregularity index
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root resorption
Time Frame: 6 month
CBCT evaluation of root resorption
6 month

Collaborators and Investigators

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

Sponsor

Haidy Fekry

Investigators

  • Principal Investigator: samir A ibrahim, proffesor, Al Azhar Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

April 15, 2022

Primary Completion (Actual)

April 10, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO-109-2-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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