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Root Torque Control in Cases Treated With Direct Printed Aligners

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07273552
Acronym
CBCT
Enrollment
14
Registered
2025-12-09
Start date
2025-06-01
Completion date
2026-07-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Direct Printed Aligners on Root Torque

Keywords

Direct printed aligners torque

Brief summary

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.

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.

Interventions

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.

Sponsors

British University In Egypt
CollaboratorOTHER
Beni-Suef University
CollaboratorOTHER
Suez Canal University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .9-12 months

Secondary

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

Countries

Egypt

Contacts

Primary ContactRim M Fathalla, PhD of Orthodontics
rim_fathalla@dent.suez.edu.eg00201222726567
Backup ContactRehab Khalil, PhD of Orthodontics
rehababdelrazek@dent.bsu.edu.eg00201005230669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026