3D‑printed shape‑memory clear aligners for closing anterior open bite
Official title: Evaluating the Effectiveness of 3D Directly Printed Shape Memory Aligners in the Management of Anterior Open Bite
Run by Kufa University · NCT07420777 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 35 Years |
| Sex | All |
| Enrollment | 51 (estimated) |
| Sponsor | Kufa University Academic / other |
| Locations | 1 site (Erbil, Erbil Governorate) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | December 26, 2026 |
| Study ends | March 27, 2027 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07420777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.