CClinicalTrials.gg
Status unknownNCT04387175Updated Nov 9, 2020

Intraoral Device vs Facial Mask for Class III Treatment

An interventional study of Carriere Motion 3D Class III Appliance and Facial mask in Class III Malocclusion and Dentofacial Anomalies, Including Malocclusion, sponsored by Azienda Ospedaliero-Universitaria Careggi. Status unknown. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2020-11-09.

Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

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.

02

Conditions studied

  • Class III Malocclusion
  • Dentofacial Anomalies, Including Malocclusion
03

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Carriere Motion 3D Class III Appliance

    Device: Carriere Motion 3D Class III Appliance

  • Active comparator
    Facial mask

    Device: Facial mask

Interventions

  • DeviceCarriere 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.

  • DeviceFacial 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.

05

What researchers measure

Primary outcomes

  1. Wits appraisal

    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)

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04387175
Lead sponsor
Azienda Ospedaliero-Universitaria Careggi
Responsible party
Lorenzo Franchi, DDS, PhD (Associate Professsor, Azienda Ospedaliero-Universitaria Careggi) — Principal investigator
First posted
May 13, 2020
Start date
Jan 11, 2021 (estimated)
Primary completion
Jan 31, 2023 (estimated)
Completion
Jan 31, 2023 (estimated)
Last update
Nov 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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