Angle Class II
Conditions
Keywords
amda®, maxillary molar distalization, randomized controlled trial, orthodontics
Brief summary
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.
Detailed description
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of: * Group I: patients treated with amda® * Group II: patients treated with buccal mini-implants 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: * point T0: baseline data - before initiation of the treatment * point T1: immediately after distalization (8-12 months)
Interventions
DEVICEAdvanced Molar Distalization Appliance (amda®)
AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
DEVICEBuccal mini-implants
Buccal mini-implants for maxillary molar distalization
Sponsors
Aristotle University Of Thessaloniki
Grigore T. Popa University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two arm parallel randomized controlled trial with 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anteroposterior position changes of upper first molars. | 8-12 months | Anteroposterior position movement in mm of the upper first molars |
| Measurements on the lateral cephalograms and digital 3D model casts. | 8-12 months | Angular measurements of the lateral cephalograms and digital models |
Countries
Romania
Contacts
Primary ContactNikolaos Karvelas, PhD student
Outcome results
None listed