Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial

Azienda Ospedaliero-Universitaria Careggi0 sites32 target enrollmentJanuary 11, 2021

ConditionsClass III Malocclusion Dentofacial Anomalies, Including Malocclusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Class III Malocclusion
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Enrollment: 32
Primary Endpoint: Wits appraisal
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the Carriere® Motion 3D™ Class III Appliance) with the facial mask for the early treatemnt of Class III malocclusion. This is a monocentric, parallel, controlled trial with blinded examiner.

Registry

clinicaltrials.gov

Start Date

January 11, 2021

End Date

January 31, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Responsible Party

Principal Investigator

Lorenzo Franchi, DDS, PhD

Associate Professsor

Azienda Ospedaliero-Universitaria Careggi

Eligibility Criteria

Inclusion Criteria

•age between 5 and 8 years
•prepubertal patients (cervical vertebral stage 1 or 2)
•Deciduous, early mixed, and intermediate mixed dentition (the lower deciduous canine should show at least 2/3 of the roots unresorbed)
•Presence of Class III skeletal imbalance (Wits appraisal equal to or smaller than

Exclusion Criteria

•Early root resorption of the lower deciduous canines
•Periodontal disease
•Neurologic diseases
•Nickel allergy
•Patients with cleft lip and palate or craniofacial syndromes
•Patients irradiated in the head and neck area
•Patients who have undergone chemiotherapy or immunosuppresive therapy in the previous 5 years
•Patients unable to be followed for at least 1 year