MalocclusionNCT02603289
One Week Aligner Evaluation
An observational study of Malocclusion, run by Align Technology, Inc. at 24 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Invisalign
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Sep 2015to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Invisalign patients from selected pool of investigators
Who may be able to join
- Subject must have fully erupted dentition except for 2nd and 3rd molars
- For Teen treatment group, subjects ages <17 years of age
- For Adult treatment group, subjects ≥17 years of age
Who cannot join
- Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- Subject with active caries
- Subject with periodontal disease
- Subject with TMD symptoms
- Subject has known allergy to latex or plastic
- Subjects who are pregnant or will become pregnant during treatment
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Dr. Thomas Everett
Burnsville, Minnesota, 55306
Dr. Vincent D'Ascoli
Carson City, Nevada, 89701
Dr. Justin Wild
Eden Prairie, Minnesota, 55344
Dr. Jeff Mastroianni
Glen Carbon, Illinois, 62034
Dr. David Chenin
Henderson, Nevada, 89052
Dr. Regina Blevins
Inver Grove Heights, Minnesota, 55076
Dr. Thomas Marcel
Livermore, California, 94550
Dr. Anil Idiculla
Lone Tree, Colorado, 80124
Dr. Mark Perelmuter
Louisville, Kentucky, 40207
Dr. Zvi Kennet
Macomb, Michigan, 48044
Dr. William Kottemann
Maple Grove, Minnesota, 55369
Dr. Carlyn Phucas
Marlton, New Jersey, 08053
Dr. Ryan Caudill
Merritt Island, Florida, 32953
Dr. David Paquette
Mooresville, North Carolina, 28117
Dr. Mary Cooke
Napa, California, 94558
Dr. Brian Amy
Oklahoma City, Oklahoma, 73120
Dr. Sean Holliday
Pearl City, Hawaii, 96782
Dr. James Crouse
Salisbury, Maryland, 21801
Dr. Bella Shen Garnett
San Francisco, California, 94118
Align Technology, Inc.
San Jose, California, 95131
Dr. Robery Van den Berg
San Ramon, California, 94583
Dr. Clark Colville
Seguin, Texas, 78155
Dr. William Gierie
Wilmington, North Carolina, 28405
About this study
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
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. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
- Conditions
- Malocclusion
- Being tested
- Invisalign
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvisalignDevice
| Study group | Role | What they receive |
|---|---|---|
| Teen | < 17 years of age Receives: Device: Invisalign | |
| Adult | 17 years of age or older Receives: Device: Invisalign | |
| Adult with Primer Aligners | 17 years of age or older This group will get Primer Aligners Receives: Device: Invisalign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planned to Final Tooth Position
Test vs Historical Control Group
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Treatment time
Length of treatment
Measured: Through study completion, an average of 2 years
Subject Quality of Life
Assessment of QoL
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2018
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Align Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603289
- Sponsor's protocol ID
- CSP-300313-00
- Status last verified
- Oct 2020
- First submitted
- 10 Nov 2015
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Week Aligner Evaluation
- ClinicalTrials.gov ID
- NCT02603289
- Acronym / sponsor ID
- CSP-300313-00
- Conditions
- Malocclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Align Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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 purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
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. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teen | – | Device: Invisalign< 17 years of age |
| Adult | – | Device: Invisalign17 years of age or older |
| Adult with Primer Aligners | – | Device: Invisalign17 years of age or older This group will get Primer Aligners |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invisalign patients from selected pool of investigators
Key inclusion criteria (3 listed)
- Subject must have fully erupted dentition except for 2nd and 3rd molars
- For Teen treatment group, subjects ages <17 years of age
- For Adult treatment group, subjects ≥17 years of age
Key exclusion criteria (6 listed)
- Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- Subject with active caries
- Subject with periodontal disease
- Subject with TMD symptoms
- Subject has known allergy to latex or plastic
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 | Device | Adult, Adult with Primer Aligners, Teen |
Primary outcome
Planned to Final Tooth Position
Time frame: Through study completion, an average of 2 years
Test vs Historical Control Group
2 secondary outcomes
Treatment time
Time frame: Through study completion, an average of 2 years
Subject Quality of Life
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Align Technology, Inc. at 24 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 6 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Planned to Final Tooth Position (time frame: Through study completion, an average of 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 20 Oct 2020.