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NCT Number: NCT07273552

Root Torque Control in Cases Treated With Direct Printed Aligners

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.

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Key information

Conditions

Effect of Direct Printed Aligners on Root Torque

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University, Banī Suwayf, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Direct printed aligners

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.

    Time frame: 9-12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Khalil, PhD of Orthodontics

CONTACT

[email protected]

00201005230669

Rim M Fathalla, PhD of Orthodontics

CONTACT

[email protected]

00201222726567

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Collaborators

  • Beni-Suef University
  • British University In Egypt

Registry information

Official study title

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

Acronym: CBCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.