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Intraoral Device vs Facial Mask for Class III Treatment

NCT04387175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-11-09

No results posted yet for this study

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

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04387175 on ClinicalTrials.gov