Using a special appliance to move back upper molars in patients with Class II malocclusion
Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
This study is testing whether a special appliance can move back upper molars more effectively than mini-implants in people with Class II malocclusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 14 Years to 20 Years |
| Sex | All |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Iasi) |
| Trial ID | NCT06011382 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Advanced Molar Distalization Appliance (amda®) compared to buccal mini-implants for the distalization of maxillary first molars in patients with Class II malocclusion. Participants will be randomly assigned to one of two treatment groups, and their dental and skeletal changes will be assessed using lateral cephalograms and 3D digital models at baseline and after 8-12 months of treatment. The goal is to determine which method is more efficient for achieving the desired dental alignment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with permanent dentition and bilateral Class II molar relationships.
Not a fit: Patients with a history of orthodontic treatment, severe dental issues, or specific growth patterns may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with Class II malocclusion, improving their dental alignment and overall oral health.
How similar studies have performed: Other studies have explored similar orthodontic techniques, but the specific use of the amda® in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients to have permanent dentition * with or without the 2nd molar erupted * bilateral Class II molar relationships (a quarter to 1 molar cusp). Exclusion Criteria: * Past orthodontic treatment * crossbites, * severe carious lesions, * poor oral hygiene, * mobility of the maxillary first molars, * anterior open bites, * vertical growth pattern, * tongue habits.
Where this trial is running
Iasi
- University of Medicine and Pharmacy "Grigore T. Popa" — Iasi, Romania (Recruiting)
Study contacts
- Principal investigator: Nikolaos Karvelas, PhD student — Grigore T Popa University, Department of Orthodontics
- Study coordinator: Nikolaos Karvelas, PhD student
- Email: karvelas93@gmail.com
- Phone: +40 759481645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.