Actively Recruiting
Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
Led by Aristotle University Of Thessaloniki · Updated on 2025-06-27
40
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 needed
- Patients younger than 30 years old in permanent dentition with second molars erupted at least half
- Patients in good general health with healthy gums
You will not qualify if you...
- Patients with Class II malocclusion caused by mandibular deficiency or 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, palate, or other craniofacial syndromes
- Patients with missing, congenital missing, or extra teeth
- Patients with full coverage molar restorations
- Patients who had previous orthodontic treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Orthodontics, Faculty of Dentistry, School of Medical Sciences, Aristotle University of Thessaloniki
Thessaloniki, Greece, 54124
Actively Recruiting
Research Team
A
Aikaterini Samandara, Doctor of Dental Surgery
CONTACT
M
Moschos Papadopoulos, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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