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

Grigore T. Popa University of Medicine and Pharmacy

Status: Enrolling

Conditions: Angle Class II

Treatments: Device: Buccal mini-implants; Device: Advanced Molar Distalization Appliance (amda®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06011382

NKarvelas

Details and patient eligibility

About

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.

Full 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)

Enrollment: 16 estimated patients

Sex: All

Ages: 14 to 20 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

patients treated with amda®

Active Comparator group

Description:

two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.

Treatment:

Device: Advanced Molar Distalization Appliance (amda®)

patients treated with buccal mini-implants

Active Comparator group

Description:

from initiation of treatment until completion of maxillary molar distalization.

Treatment:

Device: Buccal mini-implants