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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: katerinasamandara@gmail.com
• Phone: +306945299800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing clear aligners and fixed braces for treating mild Class II malocclusion in adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.