Intraoral Device vs Facial Mask for Class III Treatment

Azienda Ospedaliero-Universitaria Careggi

Status: Unknown

Conditions: Class III Malocclusion; Dentofacial Anomalies, Including Malocclusion

Treatments: Device: Facial mask; Device: Carriere Motion 3D Class III Appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT04387175

LF5

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Carriere Motion 3D Class III Appliance

Experimental group

Treatment:

Device: Carriere Motion 3D Class III Appliance

Facial mask

Active Comparator group

Treatment:

Device: Facial mask