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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Angle Class II
• Intervention / Treatment: Device: Advanced Molar Distalization Appliance (amda®); Device: Buccal mini-implants

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 Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikolaos Karvelas, PhD student; Phone Number: +40 759481645; Email: karvelas93@gmail.com

Study Locations

• Romania
  • Iasi, Romania, 70015
    • Recruiting
    • University of Medicine and Pharmacy "Grigore T. Popa"
    • Contact: UMF Grigore T. Popa; Phone Number: +40759481645; Email: karvelas93@gmail.com
    • Principal Investigator: Nikolaos Karvelas, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients treated with amda®; two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.	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
Active Comparator: patients treated with buccal mini-implants; from initiation of treatment until completion of maxillary molar distalization.	Device: Buccal mini-implants; Buccal mini-implants for maxillary molar distalization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Collaborators: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Nikolaos Karvelas, PhD student, Grigore T Popa University, Department of Orthodontics

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; orthodontics; amda®; maxillary molar distalization
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: NKarvelas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be availaible upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No