Class II MalocclusionNCT06651944
Invisalign® System with Mandibular Advancement
A study testing Invisalign® System with mandibular advancement featuring occlusal blocks in people with Class II Malocclusion and Mandibular Advancement, run by Align Technology, Inc. at 3 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Class II Malocclusion, Mandibular Advancement, Mandibular Retrognathism
- What is being tested?
- Invisalign® System with mandibular advancement featuring occlusal blocks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesCanada
- Study dates
- 14 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be eligible for Invisalign treatment with mandibular advancement
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Srour contact
Canada3 sites, 3 recruiting
- Recruiting
Discover Orthodontics
Brampton, Ontario, L6Z 4N5
Dr. Bart Iwasiuk, DDS, (905) 846-7846, bartiwasiuk@hotmail.com
Dr. Bart Iwasiuk, DDS
- Recruiting
Astra Orthodontics
Richmond, British Columbia, BC V7C 5L9
Dr. Sandra Tai, DDS, (604) 270-7828, sandra@drsandratai.com
Dr. Sandra Tai, DDS
- Recruiting
MacKenzie Orthodontics
Saint John, New Brunswick, E2L 1G5
Dr. Liliya MacKenzie, DDS, (506) 633-0555, drliliyamackenzie@yahoo.ca
Dr. Liliya MacKenzie, DDS
About this study
Official title: 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
- Conditions
- Class II Malocclusion, Mandibular Advancement, Mandibular Retrognathism, Excessive Overjet
- Being tested
- Invisalign® System with mandibular advancement featuring occlusal blocks
- Keywords
- Class II Malocclusion, Mandibular Advancement, Invisalign, Orthodontics, Occlusal Blocks, Growing Patients
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign® System with mandibular advancement featuring occlusal blocksDevice
Class II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks
| Study group | Role | What they receive |
|---|---|---|
| Invisalign® System with Mandibular Advancement | Experimental | all participants will receive the study device Receives: Device: Invisalign® System with mandibular advancement featuring occlusal blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort and fit
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.
Measured: Through the study completion of up to 2 years
Secondary outcomes (1)
Class II correction
measured through analysis of intraoral scans
Measured: Through the study completion of up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start14 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Align Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651944
- Sponsor's protocol ID
- A005541
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data is planned to be shared with Sponsor and Investigators only
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invisalign® System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) Post-Market Study
- ClinicalTrials.gov ID
- NCT06651944
- Acronym / sponsor ID
- A005541
- Conditions
- Class II Malocclusion, Mandibular Advancement, Mandibular Retrognathism, Excessive Overjet
- Keywords
- Class II Malocclusion, Mandibular Advancement, Invisalign, Orthodontics, Occlusal Blocks, Growing Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Align Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invisalign® System with Mandibular Advancement | Experimental | Device: Invisalign® System with mandibular advancement featuring occlusal blocksall participants will receive the study device |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subject must be eligible for Invisalign treatment with mandibular advancement
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invisalign® System with mandibular advancement featuring occlusal blocksClass II correction using the Invisalign® System with mandibular advancement featuring occlusal blocks | Device | Invisalign® System with Mandibular Advancement |
Primary outcome
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.
1 secondary outcome
Class II correction
Time frame: Through the study completion of up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No. Data is planned to be shared with Sponsor and Investigators only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Srour contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign® System with mandibular advancement featuring occlusal blocks in people with Class II Malocclusion and Mandibular Advancement, run by Align Technology, Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Mossing (4083940304, amossing@aligntech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort and fit (time frame: Through the study completion of up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.