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

Primary Purpose

Angle Class II

Status
Recruiting
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Advanced Molar Distalization Appliance (amda®)
Buccal mini-implants
Sponsored by
Grigore T. Popa University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle Class II focused on measuring amda®, maxillary molar distalization, randomized controlled trial, orthodontics

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • University of Medicine and Pharmacy "Grigore T. Popa"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patients treated with amda®

patients treated with buccal mini-implants

Arm Description

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

from initiation of treatment until completion of maxillary molar distalization.

Outcomes

Primary Outcome Measures

Anteroposterior position changes of upper first molars.
Anteroposterior position movement in mm of the upper first molars
Measurements on the lateral cephalograms and digital 3D model casts.
Angular measurements of the lateral cephalograms and digital models
Measurements on the lateral cephalograms and digital 3D model casts.
Linear measurements of the lateral cephalograms and digital models

Secondary Outcome Measures

Full Information

First Posted
June 13, 2023
Last Updated
August 21, 2023
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Collaborators
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT06011382
Brief Title
Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)
Official Title
Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Collaborators
Aristotle University Of Thessaloniki

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Class II
Keywords
amda®, maxillary molar distalization, randomized controlled trial, orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arm parallel randomized controlled trial with 1:1 allocation ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients treated with amda®
Arm Type
Active Comparator
Arm Description
two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.
Arm Title
patients treated with buccal mini-implants
Arm Type
Active Comparator
Arm Description
from initiation of treatment until completion of maxillary molar distalization.
Intervention Type
Device
Intervention Name(s)
Advanced Molar Distalization Appliance (amda®)
Intervention Description
AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
Intervention Type
Device
Intervention Name(s)
Buccal mini-implants
Intervention Description
Buccal mini-implants for maxillary molar distalization
Primary Outcome Measure Information:
Title
Anteroposterior position changes of upper first molars.
Description
Anteroposterior position movement in mm of the upper first molars
Time Frame
8-12 months
Title
Measurements on the lateral cephalograms and digital 3D model casts.
Description
Angular measurements of the lateral cephalograms and digital models
Time Frame
8-12 months
Title
Measurements on the lateral cephalograms and digital 3D model casts.
Description
Linear measurements of the lateral cephalograms and digital models
Time Frame
8-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolaos Karvelas, PhD student
Phone
+40 759481645
Email
karvelas93@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Karvelas, PhD student
Organizational Affiliation
Grigore T Popa University, Department of Orthodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Pharmacy "Grigore T. Popa"
City
Iasi
ZIP/Postal Code
70015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMF Grigore T. Popa
Phone
+40759481645
Email
karvelas93@gmail.com
First Name & Middle Initial & Last Name & Degree
Nikolaos Karvelas, PhD student

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be availaible upon request

Learn more about this trial

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

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