Distalizing upper first and second molars with a palate miniscrew device versus clear aligners

Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners: A Randomized Clinical Trial.

This trial will test whether a miniscrew‑supported palate device (AMDA®) or clear aligners with Class II elastics moves upper first and second molars back more effectively in people with bilateral Class II malocclusion who need molar distalization.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: N/A to 30 Years
• Sex: All
• Sponsor: Aristotle University Of Thessaloniki (other)
• Locations: 1 site (Thessaloniki)
• Trial ID: NCT07040176 on ClinicalTrials.gov

What this trial studies

Adults and late adolescents with bilateral Class II malocclusion will be randomly assigned to either a miniscrew‑supported palatal device (AMDA®) or clear aligners (Spark®) with Class II elastics for upper molar distalization. Lateral cephalometric X‑rays and 3D intraoral scans will be taken before treatment, at the end of active distalization, and at treatment completion; CBCT scans will be taken for patients in the AMDA group at specified time points. Primary comparisons include amount of molar distalization and anchorage loss, while secondary analyses will compare movements of premolars, canines, and incisors in three planes and treatment duration. Results will show whether one approach achieves the planned Class I molar relationship with different side effects or time requirements.

Who should consider this trial

Good fit: Ideal candidates are patients under 30 in permanent dentition with at least half cusp bilateral Class II due to maxillary excess or posterior maxillary proclination, with erupted second molars and good general and periodontal health.

Not a fit: Patients whose Class II is caused by mandibular deficiency or retrusion, unilateral Class II, craniofacial syndromes (like cleft), missing or heavily restored molars, or poor periodontal health are unlikely to benefit from these distalization approaches.

Why it matters

Potential benefit: If successful, the results could help choose the method that achieves reliable upper molar distalization with less unwanted tooth movement or shorter overall treatment.

How similar studies have performed: Both miniscrew‑anchored distalization and aligner‑based distalization with elastics have shown success in prior orthodontic reports, but direct randomized head‑to‑head comparisons are limited.

Eligibility criteria

Inclusion Criteria:

* Patients with at least half cusp bilateral Class II malocclusion between upper and lower first molars due to maxillary excess or maxillary protrusion or forward movement of the maxillary posterior teeth, where maxillary molar distalization is indicated.
* Patients in the permanent dentition period of less than 30 years of age with second molars erupted at least one half.
* Patients with good general health and healthy periodontium.

Exclusion Criteria:

* Patients with Class II malocclusion between upper and lower first molars due to mandibular deficiency or mandibular retrusion.
* Patients with less than half cusp bilateral Class II malocclusion between upper and lower first molars.
* Patients with unilateral Class II malocclusion between upper and lower first molars.
* Patients with cleft lip and palate or with other craniofacial syndromes.
* Patients with missing, or congenital missing or supernumerary teeth.
* Patients with full coverage molar restorations.
* Patients with previous orthodontic treatment.

Where this trial is running

Thessaloniki

• Department of Orthodontics, Faculty of Dentistry, School of Medical Sciences, Aristotle University of Thessaloniki — Thessaloniki, Greece (RECRUITING)

Study contacts

• Study coordinator: Aikaterini Samandara, Doctor of Dental Surgery

Conditions: Distalization, Class II Malocclusion, Aligner Therapy, Distalization by Miniscrews, Class II malocclusion, Orthodontics, Aligners, Miniscrew implants