Intraoral Device vs Facial Mask for Class III Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Class III Malocclusion; Dentofacial Anomalies, Including Malocclusion
• Intervention / Treatment: Device: Carriere Motion 3D Class III Appliance; Device: Facial mask

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facial mask	Device: Facial mask; The facial mask consists of a chin pad and frontal pad connected by a central steel bar. On the central bar there is a horizontal steel bar to which latex elastic bands are attached which develop 14 ounces of force. The elastics are connected to the rapid maxillary expander by means of two hooks welded on the bands of the second upper deciduous molars or the first upper permanent molars.
Experimental: Carriere Motion 3D Class III Appliance	Device: Carriere Motion 3D Class III Appliance; The device made of stainless steel consists of a flexible bar with two pads at the end which are bonded bilaterally with composite resin to the lower second deciduous molar or the lower first permanent molar at the rear and the lower deciduous canine at the front. The base on the lower deciduous canine has a hook to which bilaterally elastic latex bands are connected with the vestibular tubes of the cemented bands on the upper deciduous second molars (Force 2 elastics ) or on the first permanent upper molars (Force 1 elastics), on whose palatine surface the a rapid maxillary expander is welded.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Anticipated): January 11, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: LF5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes