3D‑printed shape‑memory clear aligners for closing anterior open bite
Evaluating the Effectiveness of 3D Directly Printed Shape Memory Aligners in the Management of Anterior Open Bite
This trial will test whether 3D‑printed shape‑memory clear aligners can help adults (18–35) with mild–moderate anterior open bite close their bite with or without attachments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Kufa University Academic / other |
| Locations | 1 site (Erbil, Erbil Governorate) |
| Trial ID | NCT07420777 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial will compare three treatments in adults with anterior dental open bite: conventional clear aligners with attachments, 3D direct‑printed shape‑memory aligners without attachments, and 3D direct‑printed shape‑memory aligners with attachments. Fifty‑one patients (17 per group) aged 18–35 with mild‑to‑moderate open bite will be recruited in Erbil, Iraq, and treated by a specialist orthodontist. Primary outcomes include changes in overbite, molar intrusion, anterior tooth extrusion, stress distribution, and initial tooth displacement measured clinically and with imaging/modeling over the treatment period. The trial is ethically approved, randomized, and powered to detect a 1.5 mm difference in overbite between groups.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18–35 with mild to moderate anterior dental open bite, fully erupted dentition, and well‑aligned or only mildly crowded teeth.
Not a fit: Patients with severe skeletal open bites, prior trauma or endodontic treatment on key teeth, systemic bone metabolism disorders, medications that affect tooth movement, or neuromuscular deficiencies are unlikely to benefit.
Why it matters
Potential benefit: If successful, these aligners could provide a less invasive and potentially attachment‑free option to close anterior open bites.
How similar studies have performed: Conventional clear aligners with attachments have some clinical support for certain tooth movements and limited molar intrusion, but direct 3D‑printed shape‑memory aligners are largely novel with mainly laboratory or early‑stage data rather than established clinical success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-35 years, 2. Both genders. 3. The patient is well fitted with no systemic disease. 4. Mild-moderate dental anterior open bite. 5. Well-aligned or mildly crowded dentition. Exclusion Criteria: 1. Patient with a history of trauma to the molars or incisors. 2. Patient with a history of endodontic treatment to the maxillary first molar or incisors. 3. Patient with a systemic disease related to bone metabolism. 4. Patient taking immunosuppressive drugs or drugs inhibiting or accelerating tooth movement; and 5. Patient with neuromuscular deficiencies.
Where this trial is running
Erbil, Erbil Governorate
- Azadi dental center — Erbil, Erbil Governorate, Iraq (Recruiting)
Study contacts
- Study coordinator: Hasan S. Al-Nuaimi, Ph.D.
- Email: hsh.ortho@yahoo.com
- Phone: +9647711227788
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.