Control of incisor root torque with direct 3D‑printed clear 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

This will test whether direct 3D‑printed aligners can achieve planned root torque in adults (18–45) having non‑extraction orthodontic treatment for anterior spacing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Suez Canal University (Academic / other)
• Locations: 3 sites (Banī Suwayf and 2 other locations)
• Trial ID: NCT07273552 on ClinicalTrials.gov

What this trial studies

Participants will receive treatment planned from intraoral scans and will wear direct 3D‑printed aligners that are softened in warm water and changed weekly. Cone beam CT (CBCT) scans will be taken before treatment and at treatment end (within 9 months to 2 years) to measure incisor root torque, labial/palatal bone thickness, and root length. Achieved torque will be compared to planned torque to calculate efficiency (achieved/predicted × 100%) and detect any root resorption or bone changes. Fourteen cases will be enrolled across three Egyptian university centers with informed consent obtained from all participants.

Who should consider this trial

Good fit: Adults aged 18–45 with Angle Class I or II malocclusion, anterior spacing, planned non‑extraction treatment, normal probing depths, and no systemic conditions affecting bone metabolism.

Not a fit: Patients with active periodontal disease, significant crowding, those requiring extractions, or those on medications/with conditions altering bone metabolism are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could make incisor torque movements more predictable with aligners and help protect surrounding bone and root structure.

How similar studies have performed: Direct 3D‑printed aligners are relatively new and there is limited clinical evidence; laboratory and small clinical reports show promise but reliable torque control with aligners remains a known challenge.

Eligibility criteria

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.

Where this trial is running

Banī Suwayf and 2 other locations

• Beni-Suef University — Banī Suwayf, Egypt (Recruiting)
• British University in Egypt — Cairo, Egypt (Recruiting)
• Suez Canal University — Ismailia, Egypt (Recruiting)

Study contacts

• Principal investigator: Rim M Fathalla, PhD of Orthodontics — Suez Canal University
• Study coordinator: Rim M Fathalla, PhD of Orthodontics

Conditions Effect of Direct Printed Aligners on Root Torque; Direct printed aligners torque