Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)

Study Overview
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Brief Summary
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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
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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)

Official Title
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Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial

Conditions
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Angle Class II

Intervention / Treatment
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* Device: Advanced Molar Distalization Appliance (amda®)
* Device: Buccal mini-implants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arm parallel randomized controlled trial with 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients treated with amda®<br>two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization. | Device: Advanced Molar Distalization Appliance (amda®)<br>* AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization<br>|
| Active Comparator: patients treated with buccal mini-implants<br>from initiation of treatment until completion of maxillary molar distalization. | Device: Buccal mini-implants<br>* Buccal mini-implants for maxillary molar distalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anteroposterior position changes of upper first molars. | Anteroposterior position movement in mm of the upper first molars | 8-12 months | 
| Measurements on the lateral cephalograms and digital 3D model casts. | Angular measurements of the lateral cephalograms and digital models | 8-12 months | 
| Measurements on the lateral cephalograms and digital 3D model casts. | Linear measurements of the lateral cephalograms and digital models | 8-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amda®, maxillary molar distalization, randomized controlled trial, orthodontics