Invisalign® System with Mandibular Advancement

Align Technology

Status: Enrolling

Conditions: Mandibular Retrognathism; Excessive Overjet; Mandibular Advancement; Class II Malocclusion

Treatments: Device: Invisalign® System with mandibular advancement featuring occlusal blocks

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651944

A005541

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Invisalign® System with Mandibular Advancement

Experimental group

Description:

all participants will receive the study device

Treatment:

Device: Invisalign® System with mandibular advancement featuring occlusal blocks