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Intraoral Device vs Facial Mask for Class III Treatment

Not Applicable
Conditions
Dentofacial Anomalies, Including Malocclusion
Class III Malocclusion
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

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
Primary Outcome Measures
NameTimeMethod
Wits appraisalChange 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

Secondary Outcome Measures
NameTimeMethod

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