Invisalign® System with Mandibular Advancement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorAlign Technology, Inc.
About this trial
The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Subject's dentition not compatible with device or allergy to device materials
Subject who is pregnant, has active caries, periodontal disease, TMD, root resorption, has HAE (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder
Trial design
Design model
Single group
Treatments tested in this trial
Invisalign® System with mandibular advancement featuring occlusal blocks
DeviceClass II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Invisalign® System with Mandibular AdvancementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comfort and fit
Measured using quality of life surveys at the insertion, interim, and end of study visits. Measured on a scale which the subject rates from 1-Always to 5-Never on their current experience.
Time frame
Through the study completion of up to 2 yearsSecondary outcomes
1
Class II correction
measured through analysis of intraoral scans
Time frame
Through the study completion of up to 2 yearsOther outcomes
1
Class II correction
measured through analysis of cephalometric radiographs
Time frame
Through the study completion of up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov