Treatment Outcome of Clear Aligner and Traditional Fixed Appliances in Four Premolar Extraction Cases

November 17, 2025 updated by: Damascus University

Evaluation of the Apical Root Resorption in Young Adults Caused by Orthodontic Treatment of Class I Severe Crowding Cases Using Clear Aligners Versus Traditional Fixed Appliances: A Randomized Controlled Clinical Trial

Patients with severe crowding requiring the extraction of four premolars will be enrolled in this study. The degree of apical root resorption associated with using the clear aligner technique compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using cone beam computed tomography (CBCT) volumes.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the increasing number of young adults requesting esthetic orthodontic treatment, clear aligners have continued to gain widespread use, driven by greater consideration of esthetic aspects and oral health-related quality of life compared to traditional fixed orthodontic appliances. Recently, clear aligners have been used in more complex malocclusion cases that require premolar extraction. Teeth root resorption occurs due to physiological or pathological causes that lead to loss of tooth structure. Apical root resorption (ARR) is a common side effect of orthodontic treatment that requires careful investigation of its location and frequency.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Syria
      • Damascus, Syria
        • Department of Orthodontics, Faculty of Dentistry, University of Damascus

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

No

Description

Inclusion Criteria:

  • Adult patients aged 18-25 years.
  • Class I malocclusion with severe dental crowding.
  • Tooth size-arch discrepancy more than 6 mm.
  • No congenitally missing or extracted teeth (except for the wisdom teeth).
  • No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

  • Previous orthodontic treatment.
  • Presence of previously occurred ARR.
  • Patients with psychological abnormalities or systemic diseases.
  • Patients with known allergies to latex or plastic materials.

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
Experimental: Clear Aligners
Patients in this group will be treated using clear aligners.
Device: Clear Aligners
In-house 3D-fabricated clear aligners will be used.
Active Comparator: Fixed appliances
Patients in this group will be treated using ordinary fixed appliances.
Device: Traditional fixed appliances
The ordinary metallic braces will be used in a conventional manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in root length
Time Frame: First assessment: one day before the commencement of treatment (i.e., initiating orthodontic tooth movement). Second assessment: one day following the end of treatment (which is expected to occur within 12 to 18 months).

The maximum linear lengths between the root apex and incisal edges (for the anterior teeth) or the cusp tips (for the posterior teeth) will be measured on the cone-beam computed tomography (CBCT) images.

Differences between the measurements of each tooth before and after treatment provided the amount of apical root resorption in mm.

The variable will be measured for each tooth (from the central incisors to the first molars) and on both jaws.
First assessment: one day before the commencement of treatment (i.e., initiating orthodontic tooth movement). Second assessment: one day following the end of treatment (which is expected to occur within 12 to 18 months).

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Study Director: Mohammad Younis Hajeer, Faculty of Dentistry, University of Damascus
  • Principal Investigator: Samer T. Jaber, Faculty of Dentistry, University of Damascus

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

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)

November 10, 2019

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-6-2025

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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