Invisalign® System with Mandibular Advancement

October 21, 2024 updated by: Align Technology, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Richmond, British Columbia, Canada, BC V7C 5L9
        • Recruiting
        • Astra Orthodontics
        • Contact:
        • Contact:
          • Dr. Sandra Tai, DDS
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 1G5
        • Recruiting
        • MacKenzie Orthodontics
        • Contact:
        • Contact:
          • Dr. Liliya MacKenzie, DDS
    • Ontario
      • Brampton, Ontario, Canada, L6Z 4N5
        • Recruiting
        • Discover Orthodontics
        • Contact:
        • Contact:
          • Dr. Bart Iwasiuk, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Invisalign® System with Mandibular Advancement
all participants will receive the study device
Device: Invisalign® System with mandibular advancement featuring occlusal blocks
Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the study completion of up to 2 years

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Align Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A005541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is planned to be shared with Sponsor and Investigators only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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