Intraoral Device vs Facial Mask for Class III Treatment

Not Applicable

• Conditions: Dentofacial Anomalies, Including Malocclusion; Class III Malocclusion
• Interventions: Device: Carriere Motion 3D Class III Appliance; Device: Facial mask

• Registration Number: NCT04387175
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Study Start: 2021-01-11
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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
• 1 mm)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carriere Motion 3D Class III Appliance	Carriere Motion 3D Class III Appliance	-
Facial mask	Facial mask	-

Primary Outcome Measures

Name	Time	Method
Wits appraisal	Change in Wits appraisal evaluated on the lateral cephalograms taken at the start and at the end of active treatment (6-10 months)	Distance between the perpendiculars from points A and B on the maxilla and mandible, respectively, onto the occlusal plane