Class III Malocclusion Clinical Trial
Official title:
Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial
Verified date | November 2020 |
Source | Azienda Ospedaliero-Universitaria Careggi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the Carriere® Motion 3Dâ„¢ 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.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Careggi |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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