Intraoral Device vs Facial Mask for Class III Treatment

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04387175
• Other study ID #: LF5
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: November 2020
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Class III Malocclusion
• Dentofacial Anomalies, Including Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Device:
• Carriere 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.
• Facial 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Outcome

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)