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Search / Trial NCT07040176

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

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Jun 18, 2025

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

Class Ii Malocclusion Distalization Orthodontics Aligners Miniscrew Implants

ClinConnect Summary

This clinical trial is studying two different ways to move upper back teeth (called molars) backward to help correct a common bite problem known as Class II malocclusion, where the upper teeth sit too far forward compared to the lower teeth. The trial compares a special device that uses small screws implanted in the roof of the mouth (called the Advanced Molar Distalization Appliance or AMDA®) with clear, removable braces known as Spark® aligners, which are used along with rubber bands (Class II elastics). The goal is to see which method is better at moving the molars backward and how each affects the movement of other teeth, treatment time, and overall results.

People who might join this study are those under 30 years old who have a specific type of bite issue where both upper first molars are positioned too far forward, and their second molars have at least partially come in. Participants need to be generally healthy with good gum health and have not had previous orthodontic treatment. During the study, participants will visit the orthodontic clinic every 4 to 6 weeks for check-ups and will have scans, photos, and X-rays taken before, during, and after treatment to track progress. This study will help doctors understand which treatment option might work better for moving upper molars backward safely and effectively.

Gender

ALL

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.

About Aristotle University Of Thessaloniki

Aristotle University of Thessaloniki (AUTH) is a prestigious institution in Greece, renowned for its commitment to advancing knowledge and innovation in the field of clinical research. As a leading academic sponsor of clinical trials, AUTH leverages its extensive resources and expertise to conduct rigorous studies that contribute to the understanding of various medical conditions and the development of novel therapeutic interventions. The university fosters collaboration among multidisciplinary teams, ensuring adherence to the highest ethical standards and regulatory requirements while promoting scientific excellence and enhancing patient care.

Locations

Thessaloniki, , Greece

Patients applied

0 patients applied

Trial Officials

Moschos Papadopoulos, Professor

Study Chair

Aristotle University Of Thessaloniki

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported