Intraoral Device vs Facial Mask for Class III Treatment
Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial
Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial
Sponsor study identifier
interventional
32
0 countries
N/A
Study Start
January 11, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2020
Actual (reported)May 13, 2020
Actual (reported)January 11, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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.
First Submitted
May 8, 2020
First Posted
May 13, 2020
Study Start
January 11, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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.
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January 31, 2023
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 9, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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