Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Angle Class II
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Anteroposterior position changes of upper first molars.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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)
Investigators
Nikolaos Karvelas
Principal Investigator
Grigore T. Popa University of Medicine and Pharmacy
Eligibility 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.
Outcomes
Primary Outcomes
Anteroposterior position changes of upper first molars.
Time Frame: 8-12 months
Anteroposterior position movement in mm of the upper first molars
Measurements on the lateral cephalograms and digital 3D model casts.
Time Frame: 8-12 months
Linear measurements of the lateral cephalograms and digital models