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

NCT ID: NCT06011382

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2025-06-20

Brief Summary

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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

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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)

Conditions

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Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm parallel randomized controlled trial with 1:1 allocation ratio
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients treated with amda®

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

Group Type ACTIVE_COMPARATOR

Advanced Molar Distalization Appliance (amda®)

Intervention Type 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 buccal mini-implants

from initiation of treatment until completion of maxillary molar distalization.

Group Type ACTIVE_COMPARATOR

Buccal mini-implants

Intervention Type DEVICE

Buccal mini-implants for maxillary molar distalization

Interventions

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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

Intervention Type DEVICE

Buccal mini-implants

Buccal mini-implants for maxillary molar distalization

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

Grigore T. Popa University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Karvelas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolaos Karvelas, PhD student

Role: PRINCIPAL_INVESTIGATOR

Grigore T Popa University, Department of Orthodontics

Locations

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University of Medicine and Pharmacy "Grigore T. Popa"

Iași, , Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Nikolaos Karvelas, PhD student

Role: CONTACT

+40 759481645

Facility Contacts

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UMF Grigore T. Popa

Role: primary

+40759481645

Other Identifiers

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NKarvelas

Identifier Type: -

Identifier Source: org_study_id

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