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

NCT06011382 | Unknown DMC

• 1 other identifier: NKarvelas
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Angle Class II

Keywords

amda®; maxillary molar distalization; randomized controlled trial; orthodontics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

patients treated with amda®

ACTIVE COMPARATOR

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

Device: Advanced Molar Distalization Appliance (amda®)

patients treated with buccal mini-implants

ACTIVE COMPARATOR

from initiation of treatment until completion of maxillary molar distalization.

Device: Buccal mini-implants

Interventions

Advanced Molar Distalization Appliance (amda®) DEVICE

AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization

patients treated with amda®

Buccal mini-implants DEVICE

Buccal mini-implants for maxillary molar distalization

patients treated with buccal mini-implants

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients to have permanent dentition
• with or without the 2nd molar erupted
• bilateral Class II molar relationships (a quarter to 1 molar cusp).

You may not qualify if:

• Past orthodontic treatment
• crossbites,
• severe carious lesions,
• poor oral hygiene,
• mobility of the maxillary first molars,
• anterior open bites,
• vertical growth pattern,
• tongue habits.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

University of Medicine and Pharmacy "Grigore T. Popa"

Iași, 70015, Romania

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nikolaos Karvelas, PhD student

  Grigore T Popa University, Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos Karvelas, PhD student

CONTACT

+40 759481645; karvelas93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arm parallel randomized controlled trial with 1:1 allocation ratio

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 25, 2023
• Study Start: June 20, 2022
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)