Direct 3D-printed aligners for moving upper and lower incisor crowns
Comparison of Predicted and Achieved Crown Movements in Adult Spacing Cases Treated With 3D Direct-printed Aligners: A Prospective Clinical Trial
This study tests whether direct 3D-printed aligners can achieve the planned crown movement of upper and lower incisors in adults with spacing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (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 | NCT07273435 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll 23 adult patients with anterior spacing and normal skeletal relationships at three Egyptian university dental clinics. Each patient will receive intraoral scans and a 3D treatment simulation to plan crown movements, after which direct 3D-printed aligners will be fabricated. Patients will wear the aligners (warmed before insertion to activate shape memory) and change them weekly while clinicians compare actual tooth positions to the predicted movements. Outcomes focus on the accuracy and efficiency of crown movement during space closure for upper and lower incisors.
Who should consider this trial
Good fit: Adults aged 18–45 with full permanent dentition (excluding third molars), generalized or localized anterior spacing, Angle Class I or mild Class II relationships, and no significant periodontal disease are ideal candidates.
Not a fit: Patients with crowding, missing permanent teeth, active periodontal disease, severe skeletal Class II/III discrepancies, or medical conditions affecting bone metabolism are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could deliver more accurate tooth movements with direct-printed aligners, potentially reducing the need for refinements and shortening treatment time.
How similar studies have performed: Preliminary reports and small series suggest 3D-printed aligners are feasible, but there are limited data specifically quantifying crown-movement accuracy compared with digital predictions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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
- Email: rim_fathalla@dent.suez.edu.eg
- Phone: 00201222726567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.