Intraoral Device vs Facial Mask for Class III Treatment

NCT04387175 | Unknown FDA Device

• 1 other identifier: LF5
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Class III Malocclusion; Dentofacial Anomalies, Including Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Carriere Motion 3D Class III Appliance

EXPERIMENTAL

Device: Carriere Motion 3D Class III Appliance

Facial mask

ACTIVE COMPARATOR

Device: Facial mask

Interventions

Carriere Motion 3D Class III Appliance DEVICE

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.

Carriere Motion 3D Class III Appliance

Facial mask DEVICE

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.

Facial mask

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• mm)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professsor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: January 11, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share