MalocclusionNCT02376829
Class II Correction Study Using the Invisalign System
A study testing Invisalign System in people with Malocclusion, run by Align Technology, Inc. at 10 sites in 2 countries.
Trial summary
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Invisalign System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2015to 23 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject must have fully erupted dentition excluding 2nd and 3rd molars
- Age range 11-19 years old
- Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship
Who cannot join
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has spaces between adjacent teeth larger than 3mm
- Subject with active caries
- Subject with periodontal disease
- Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
- Subject with TMD (Temporomandibular joint dysfunction) symptoms
Show all 9Show fewer
- Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
- Subject has known allergy to latex and plastic
- Subjects who are pregnant or will become pregnant during treatment
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Dr. Barry Glaser
Cortlandt Manor, New York, 10567
Dr. Sandra Selnick
Ellicott City, Maryland, 21042
Dr. Regina Blevins
Inver Grove Heights, Minnesota, 55076
Dr. William Kottemann
Maple Grove, Minnesota, 55369
Dr. Donna Galante
Rocklin, California, 95765
Dr. Mark Holt
Roseville, California, 95661
Dr. Ray Kubisch and Dr. Drew Ferris
Santa Barbara, California, 93105
Dr. Gary Brigham
Scottsdale, Arizona, 85260
Canada2 sites
Dr. Sam Daher
Vancouver, British Columbia
Dr. Sandra Tai
Vancouver, British Columbia
About this study
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Read the detailed description
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
- Conditions
- Malocclusion
- Being tested
- Invisalign System
- Keywords
- Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign SystemDevice
The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
| Study group | Role | What they receive |
|---|---|---|
| The Invisalign System | Experimental | Class II correction of malocclusions Receives: Device: Invisalign System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tooth Movement at the End of Class II Correction.
The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month).
Measured: End of Class II Correction up to 18 months
Secondary outcomes (3)
Length of Treatment Time
This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
Measured: End of Treatment approximately 2 years
Patient Quality of Life Questionnaire Throughout Treatment
As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings.
Measured: End of Treatment approximately 2 years
Doctor Survey for Satisfaction With Treatment Outcomes
Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better satisfaction experience .
Measured: End of Treatment approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Align Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherri Wilson-Lopes, Study director, Align Technology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376829
- Sponsor's protocol ID
- MRF-002
- Status last verified
- May 2023
- First submitted
- 11 Feb 2015
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Class II Correction Study Using the Invisalign System
- ClinicalTrials.gov ID
- NCT02376829
- Acronym / sponsor ID
- MRF-002
- Conditions
- Malocclusion
- Keywords
- Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Align Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Detailed description
The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Invisalign System | Experimental | Device: Invisalign SystemClass II correction of malocclusions |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subject must have fully erupted dentition excluding 2nd and 3rd molars
- Age range 11-19 years old
- Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship
Key exclusion criteria (9 listed)
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has spaces between adjacent teeth larger than 3mm
- Subject with active caries
- Subject with periodontal disease
- Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
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 SystemThe Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion | Device | The Invisalign System |
Primary outcome
Rate of Tooth Movement at the End of Class II Correction.
Time frame: End of Class II Correction up to 18 months
The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month).
3 secondary outcomes
Length of Treatment Time
Time frame: End of Treatment approximately 2 years
Patient Quality of Life Questionnaire Throughout Treatment
Time frame: End of Treatment approximately 2 years
Doctor Survey for Satisfaction With Treatment Outcomes
Time frame: End of Treatment approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Sherri Wilson-Lopes study director
Align Technology, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign System in people with Malocclusion, run by Align Technology, Inc. at 10 sites in 2 countries.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Tooth Movement at the End of Class II Correction. (time frame: End of Class II Correction up to 18 months). 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 6 May 2023.