Invisalign® System with Mandibular Advancement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Class II Malocclusion Mandibular Advancement Mandibular Retrognathism Excessive Overjet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Invisalign® System with Mandibular Advancement

all participants will receive the study device

Group Type EXPERIMENTAL

Invisalign® System with mandibular advancement featuring occlusal blocks

Intervention Type DEVICE

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

Interventions

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Invisalign® System with mandibular advancement featuring occlusal blocks

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No