Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

January 9, 2023 updated by: Obaida Khaleel Ibrahim, Al-Azhar University

Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study

The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Not yet recruiting
        • Al Azhar University
        • Contact:
    • Or
      • Cairo, Or, Egypt
        • Recruiting
        • AlAzhar Azhar University
        • Contact:

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

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy systemic condition/no systemic illness, as reported by patients.
  • No use any form of anti - inflammatory drugs the at beginning of study.
  • Good oral hygiene.
  • Cooperative and motivated.
  • In the permanent dentition with all teeth present ( except third molars).
  • Minimum to moderate anterior crowding.
  • No previous orthodontic treatment.

Exclusion Criteria:

  • Previous upper removable orthodontic treatment.
  • Patients who required surgery to correct skeletal discrepancies.
  • Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
  • Uncooperative patients.
  • Patients with poor oral hygiene.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: leveling and alignment using fixed orthodontic appliance
Other: Leveling and alignment
Root resorption comparison through the use of CBCT
Experimental: leveling and alignment using clear aligner
Other: Leveling and alignment
Root resorption comparison through the use of CBCT
Experimental: leveling and alignment using clear aligner with low level laser therapy
Other: Leveling and alignment
Root resorption comparison through the use of CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Root resorption
Time Frame: 8 months
Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software
8 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Study Director: Ahmed M Abouelnour, Lecturer, Lecturer, Department of Orthodontics
  • Study Chair: Ramadan Y Aboushahba, Associate professor, Associate professor, Department of Orthodontics

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 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 357/1150

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

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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