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Intraoral Device vs Facial Mask for Class III Treatment

Primary Purpose

Class III Malocclusion, Dentofacial Anomalies, Including Malocclusion

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Carriere Motion 3D Class III Appliance

Facial mask

About this trial

This is an interventional treatment trial for Class III Malocclusion

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carriere Motion 3D Class III Appliance

Facial mask

Arm Description

Outcomes

Primary Outcome Measures

Wits appraisal

Distance between the perpendiculars from points A and B on the maxilla and mandible, respectively, onto the occlusal plane

Secondary Outcome Measures

Full Information

NCT ID

NCT04387175

First Posted

May 8, 2020

Last Updated

November 6, 2020

Sponsor

Azienda Ospedaliero-Universitaria Careggi

1. Study Identification

Unique Protocol Identification Number

NCT04387175

Brief Title

Intraoral Device vs Facial Mask for Class III Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 11, 2021 (Anticipated)

Primary Completion Date

January 31, 2023 (Anticipated)

Study Completion Date

January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Class III Malocclusion, Dentofacial Anomalies, Including Malocclusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carriere Motion 3D Class III Appliance

Arm Type

Experimental

Arm Title

Facial mask

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Carriere Motion 3D Class III Appliance

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Facial mask

Intervention Description

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.

Primary Outcome Measure Information:

Title

Wits appraisal

Description

Distance between the perpendiculars from points A and B on the maxilla and mandible, respectively, onto the occlusal plane

Time Frame

Change in Wits appraisal evaluated on the lateral cephalograms taken at the start and at the end of active treatment (6-10 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intraoral Device vs Facial Mask for Class III Treatment

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