Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.

Recruiting now · Not applicable

Conditions studied: Distalization, Class II Malocclusion, Aligner Therapy, Distalization by Miniscrews

In brief

The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. The main questions it aims to answer are: Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase? Is there any difference between the two groups in the anchorage loss at the end of total treatment? Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion. Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.

Key facts

Study ID: NCT07040176
Run by: Aristotle University Of Thessaloniki
People needed: 40
Starts: 2024-04-10
Expected to finish: 2028-04-01
Last updated by the study team: 2025-06-27

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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