NCT07040176 Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
| NCT ID | NCT07040176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Distalization |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-10 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Moschos Papadopoulos, Professor
STUDY CHAIR
Aristotle University Of Thessaloniki
Frequently Asked Questions
Who can join the NCT07040176 clinical trial?
This trial is open to participants of all sexes, up to 30 Years, studying Distalization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07040176 currently recruiting?
Yes, NCT07040176 is actively recruiting participants. Contact the research team at katerinasamandara@gmail.com for enrollment information.
Where is the NCT07040176 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT07040176 clinical trial?
NCT07040176 is sponsored by Aristotle University Of Thessaloniki. The principal investigator is Moschos Papadopoulos, Professor at Aristotle University Of Thessaloniki. The trial plans to enroll 40 participants.