Invisalign® System with Mandibular Advancement
1 other identifier
interventional
36
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2024
CompletedFirst Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 23, 2024
October 1, 2024
2.9 years
October 17, 2024
October 21, 2024
Conditions
Keywords
Outcome Measures
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.
Through the study completion of up to 2 years
Secondary Outcomes (1)
Class II correction
Through the study completion of up to 2 years
Other Outcomes (1)
Class II correction
Through the study completion of up to 2 years
Study Arms (1)
Invisalign® System with Mandibular Advancement
EXPERIMENTALall participants will receive the study device
Interventions
Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks
Eligibility Criteria
You may qualify if:
- Subject must be eligible for Invisalign treatment with mandibular advancement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Astra Orthodontics
Richmond, British Columbia, BC V7C 5L9, Canada
MacKenzie Orthodontics
Saint John, New Brunswick, E2L 1G5, Canada
Discover Orthodontics
Brampton, Ontario, L6Z 4N5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 22, 2024
Study Start
February 14, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Data is planned to be shared with Sponsor and Investigators only