Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Clear Aligner Versus Fixed Appliances

January 28, 2025 updated by: Amira Osama Elshall, Faculty of Dental Medicine for Girls

Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Treated with Clear Aligner Versus Fixed Appliances

evaluate root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
    • Naser City
      • Cairo, Naser City, Egypt, 11788
        • Faculty of Dental Medicine

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: 1. Patients with anterior spacing as less than 2mm for anterior 2. Age range from 14 to 22 years old with no sex discrimination. 3. Good oral hygiene. 4. Presence of all permanent teeth not including third molars. 5. Provide informed consent and willingness to cooperate with study protocol.

Exclusion Criteria:

  1. Medical problems or craniofacial disorders known to affect bone remodeling.
  2. Congenital defect or deformed anterior teeth.
  3. Presence of chronic or acute periodontal disease.
  4. Radiographic evidence of bone loss.
  5. History of systemic disease.
  6. Previous orthodontic treatment.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aligner
intervention patient treated with clear aligner therapy
Procedure: clear aligner
closing of spacing in anterior teeth with clear aligner therapy
Active Comparator: fixed appliance
patient treated with conventional appliance
Procedure: orthodontic treatment
conventional fixed orthodontic appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
root parallelism
Time Frame: 6 months
root angulation
6 months

Collaborators and Investigators

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

Sponsor

Faculty of Dental Medicine for Girls

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, 2023

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-OR-23-09

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

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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