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Recruiting

NCT Number: NCT06651944

Invisalign® System with Mandibular Advancement

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

Recruiting

Interested in participating?

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Key information

Conditions

Class II Malocclusion Excessive Overjet Malocclusion Malocclusion, Angle Class II Mandibular Advancement Mandibular Retrognathism Overbite Stomatognathic Diseases Tooth Diseases

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astra Orthodontics, Richmond, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invisalign® System with mandibular advancement featuring occlusal blocks

Device

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

Primary outcomes

  1. Comfort and fit

    Time frame: 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 outcomes

  1. Class II correction

    Time frame: Through the study completion of up to 2 years

    measured through analysis of intraoral scans

Other outcomes

  1. Class II correction

    Time frame: Through the study completion of up to 2 years

    measured through analysis of cephalometric radiographs

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Mossing

CONTACT

[email protected]

4083940304

Karen Srour

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Align Technology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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