Intraoral Device vs Facial Mask for Class III Treatment
NCT ID: NCT04387175
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2021-01-11
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Carriere Motion 3D Class III Appliance
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.
Facial mask
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
8 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Lorenzo Franchi, DDS, PhD
Associate Professsor
Other Identifiers
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LF5
Identifier Type: -
Identifier Source: org_study_id