An interventional study of Advanced Molar Distalization Appliance (amda®) and Buccal mini-implants in Angle Class II, sponsored by Grigore T. Popa University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 14 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Grigore T. Popa University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:
More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's planned enrollment of 16 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Grigore T. Popa University of Medicine and Pharmacy is the lead sponsor of 32 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.
Device: Advanced Molar Distalization Appliance (amda®)
from initiation of treatment until completion of maxillary molar distalization.
Device: Buccal mini-implants
AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
Buccal mini-implants for maxillary molar distalization
Anteroposterior position changes of upper first molars.
Anteroposterior position movement in mm of the upper first molars
Time frame: 8-12 months
Measurements on the lateral cephalograms and digital 3D model casts.
Angular measurements of the lateral cephalograms and digital models
Time frame: 8-12 months
Measurements on the lateral cephalograms and digital 3D model casts.
Linear measurements of the lateral cephalograms and digital models
Time frame: 8-12 months
Plan to share: No — The data will be availaible upon request
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Malocclusion, Angle Class II →
Grigore T. Popa University of Medicine and Pharmacy