Using Invisalign with special blocks for jaw advancement
Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study
This study tests if using special blocks with Invisalign can help people with jaw alignment issues feel more comfortable and improve their dental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | Align Technology, Inc. Industry-sponsored |
| Locations | 3 sites (Richmond, British Columbia and 2 other locations) |
| Trial ID | NCT06651944 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the comfort and fit of Invisalign aligners that incorporate occlusal blocks for mandibular advancement. Participants will be monitored for their engagement with the blocks while undergoing treatment for Class II malocclusion and related conditions. The study focuses on assessing how well these aligners perform in improving jaw alignment and overall dental health. The methodology involves direct observation and feedback from participants throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates are individuals eligible for Invisalign treatment who require mandibular advancement.
Not a fit: Patients with incompatible dentition, allergies to device materials, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of orthodontic treatment for patients with jaw alignment issues.
How similar studies have performed: While there have been studies on Invisalign, the specific combination of mandibular advancement with occlusal blocks is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, British Columbia and 2 other locations
- Astra Orthodontics — Richmond, British Columbia, Canada (Recruiting)
- MacKenzie Orthodontics — Saint John, New Brunswick, Canada (Recruiting)
- Discover Orthodontics — Brampton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Allison Mossing
- Email: amossing@aligntech.com
- Phone: 4083940304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.