NCT06651944RecruitingNot Applicable
Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study
Align Technology, Inc.6 sites in 1 country36 target enrollmentStarted: February 14, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Align Technology, Inc.
- Enrollment
- 36
- Locations
- 6
- Primary Endpoint
- Comfort and fit
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be eligible for Invisalign treatment with mandibular advancement
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Comfort and fit
Time Frame: Through the study completion of up to 2 years
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.
Secondary Outcomes
- Class II correction(Through the study completion of up to 2 years)
Investigators
Study Sites (6)
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