Root Torque Control in Cases Treated With Direct Printed Aligners (CBCT)

November 27, 2025 updated by: rim fathalla, Suez Canal University

Efficacy of Root Torque Control in Adult Non-extraction Spacing Cases Treated With Directly 3D Printed Clear Aligners: a Cone Beam Computed Tomography Study

This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be recruited from the Faculty of Dentistry, Beni Suef, Suez Canal, and British Universities. All subjects will be informed of the treatment procedures and will sign a consent form.

the minimum total required sample size (n) was found to be (14) cases. The sample size was calculated using R statistical analysis software version 4.5.0 for Windows[11].

Methodology:

  • Cone beam computed tomography scans will be done before treatment (T0).
  • Intraoral scanning of the patients will be performed by using an intraoral scanner to obtain pre-treatment digital models of the upper and lower arches. The treatment plan will be set up, and the aligners will be 3D printed.
  • The patient will be instructed to immerse the aligners in warm water before inserting them into the mouth to soften them and improve their fit. The patient will be instructed to change the aligners every week.
  • At the end of orthodontic treatment (within 9 months - 2 years after the beginning of the treatment), a post-treatment CBCT scan will be obtained (T1)
  • The achieved torque movement of the upper and lower incisors will be calculated by evaluated the pre and post CBCT scans taking the difference between T0 and T1.
  • The difference between achieved and predicted torque movement (DAPM) will be obtained, and the efficiency will be calculated by dividing the achieved movement / predicted movement X 100 %
  • The labial and palatal bone thickness and root length of the upper and lower incisors will be measured at T0 and T1 by using the pre and post cone-beam computed tomography, and the difference will be calculated.

The results will be obtained and statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

14

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
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni-Suef University
        • Contact:
        • Principal Investigator:
          • Rehab M Khalil, PhD of Orthodontics
      • Cairo, Egypt
        • Recruiting
        • British University In Egypt
        • Contact:
        • Principal Investigator:
          • Ahmad Elshennawy, Master of Orthodontics
      • Ismailia, Egypt
        • Recruiting
        • Suez Canal University
        • Contact:
        • Principal Investigator:
          • Rim M Fathalla, PhD of Orthodontics

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:

  1. Age: 18- 45 years old.
  2. Non- extraction treatment.
  3. Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
  4. Normal probing depth.

Exclusion Criteria:

  1. Active periodontal disease.
  2. Crowding cases.
  3. Systemic diseases or medications that alter bone metabolism or tooth movement.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with spacing
Patients will receive direct printed aligners to treat the spacing
Other: Direct printed aligners
After intraoral scanning and CBCT taking, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post-CBCT scan will be taken from each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .
Time Frame: 9-12 months
9-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the bone thickness (measured in mm) around the upper and lower incisors associated with the achieved root torque.
Time Frame: 9-12 months
9-12 months
Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.
Time Frame: 9-12 months
9-12 months

Collaborators and Investigators

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

Sponsor

Suez Canal University

Collaborators

Beni-Suef University
British University In Egypt

Investigators

  • Principal Investigator: Rim M Fathalla, PhD of Orthodontics, Suez Canal University

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)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #REC-FDBSU/08052025-01/AR

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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