Invisalign® System with Mandibular Advancement

Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06651944

Enrollment

Registered

2024-10-22

Start date

2024-02-14

Completion date

2026-12-31

Last updated

2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Malocclusion, Excessive Overjet, Mandibular Advancement, Mandibular Retrognathism

Keywords

Class II Malocclusion, Mandibular Advancement, Invisalign, Orthodontics, Occlusal Blocks, Growing Patients

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

Interventions

DEVICEInvisalign® System with mandibular advancement featuring occlusal blocks

Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Class II correction	Through the study completion of up to 2 years	measured through analysis of intraoral scans

Other

Measure	Time frame	Description
Class II correction	Through the study completion of up to 2 years	measured through analysis of cephalometric radiographs

Countries

Canada

Contacts

Primary ContactAllison Mossing

amossing@aligntech.com4083940304

Backup ContactKaren Srour

kgarcia@aligntech.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026