Class III Malocclusion, Dentofacial Anomalies, Including Malocclusion
Conditions
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.
Interventions
DEVICECarriere 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.
DEVICEFacial 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.
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed