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

Angle Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011382
• Other study ID #: NKarvelas
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: June 20, 2025

Study information

• Verified date: August 2023
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Nikolaos Karvelas, PhD student
• Phone: +40 759481645
• Email: karvelas93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 20, 2025
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angle Class II
• Malocclusion, Angle Class II

Intervention

Device:
• Advanced 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
• Buccal mini-implants
Buccal mini-implants for maxillary molar distalization

Locations

Country	Name	City	State
Romania	University of Medicine and Pharmacy "Grigore T. Popa"	Iasi

Sponsors (2)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy	Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Romania, 

Outcome

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