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

Not Applicable

Recruiting

• Conditions: Angle Class II
• Interventions: Device: Advanced Molar Distalization Appliance (amda®); Device: Buccal mini-implants

• Registration Number: NCT06011382
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

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)

Study Timeline

• Study Start: 2022-06-20
• Study First Submitted: 2023-06-13
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients treated with amda®	Advanced Molar Distalization Appliance (amda®)	two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.
patients treated with buccal mini-implants	Buccal mini-implants	from initiation of treatment until completion of maxillary molar distalization.

Primary Outcome Measures

Name	Time	Method
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	Linear measurements of the lateral cephalograms and digital models

Trial Locations

Locations (1)

University of Medicine and Pharmacy "Grigore T. Popa"; 🇷🇴 Iasi, Romania