Invisalign® System with Mandibular Advancement
Not Applicable
Recruiting
- Conditions
- Class II MalocclusionMandibular AdvancementMandibular RetrognathismExcessive Overjet
- Registration Number
- NCT06651944
- Lead Sponsor
- Align Technology, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Comfort and fit 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 Outcome Measures
Name Time Method Class II correction Through the study completion of up to 2 years measured through analysis of intraoral scans
Trial Locations
- Locations (3)
Astra Orthodontics
🇨🇦Richmond, British Columbia, Canada
MacKenzie Orthodontics
🇨🇦Saint John, New Brunswick, Canada
Discover Orthodontics
🇨🇦Brampton, Ontario, Canada