Recruiting

Invisalign® with Mandibular Advancement

Sponsor:

Align Technology, Inc.

Code:

NCT06651944

Conditions

Class II Malocclusion

Mandibular Advancement

Mandibular Retrognathism

Excessive Overjet

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

Interventions

Invisalign® System with mandibular advancement featuring occlusal blocks

Study Details

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

Conditions

Class II Malocclusion

Mandibular Advancement

Mandibular Retrognathism

Excessive Overjet

Study ID

NCT06651944

Start date

Feb 14, 2024

Status verified date

Oct, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Invisalign® System with Mandibular Advancement

all participants will receive the study device

Interventions

Invisalign® System with mandibular advancement featuring occlusal blocks

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

Primary outcome measure

  • Comfort and fit [ Time Frame: Through the study completion of up to 2 years ]

Central Contacts and Locations

Central contacts

Allison Mossing

4083940304amossing@aligntech.com

Karen Srour

kgarcia@aligntech.com

Locations

Astra Orthodontics

Recruiting

Richmond, British Columbia, Canada, BC V7C 5L9

Contacts

Dr. Sandra Tai, DDS

(604) 270-7828sandra@drsandratai.com

MacKenzie Orthodontics

Recruiting

Saint John, New Brunswick, Canada, E2L 1G5

Contacts

Dr. Liliya MacKenzie, DDS

(506) 633-0555drliliyamackenzie@yahoo.ca

Discover Orthodontics

Recruiting

Brampton, Ontario, Canada, L6Z 4N5

Contacts

Dr. Bart Iwasiuk, DDS

(905) 846-7846bartiwasiuk@hotmail.com

More Information

Sponsor

Align Technology, Inc.

Last update posted

Oct 23, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Align Technology, Inc. on 2024-10-23.