Intraoral Device vs Facial Mask for Class III Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Class III Malocclusion, Dentofacial Anomalies, Including Malocclusion

Intervention / Treatment
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* Device: Carriere Motion 3D Class III Appliance
* Device: Facial mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carriere Motion 3D Class III Appliance<br> | Device: Carriere Motion 3D Class III Appliance<br>* 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.<br>|
| Active Comparator: Facial mask<br> | Device: Facial mask<br>* 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.<br>|

What is the study measuring?
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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) |