MalocclusionNCT03141788
Evaluation of Clear Aligner Trays to Straighten Teeth
A study testing Clear Aligner in people with Malocclusion, run by Solventum Orthodontics Corporation at 9 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Clear Aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jan 2017to 9 Oct 2019
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject is at least 14 years of age.
- Subject is willing and able to give informed consent.
- Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
- Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
- Subject has good oral hygiene defined by the orthodontist.
- Subject has only permanent dentition.
Who cannot join
- Subject has skeletal discrepancies requiring surgery
- Subject is undergoing active dental work
- Subject has severe open bite > 2 mm
- Subject has severe overjet > 4 mm
- Subject has deep bite > 3 mm
- Subject has over crowding per arch > 4 mm
Show all 9Show fewer
- Subject has dental prostheses/implants that will interfere with projected teeth movement
- Subject is taking systemic steroid medication
- Subject is taking Biphosphonates or any other medication for treatment of osteoporosis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Orthodontics Associates
Catonsville, Maryland, 21228
Benson Orthodontics
Denver, Colorado, 80209-3244
Mellion Orthodontics
Fairlawn, Ohio, 44333
Depew Orthodontics
Kennesaw, Georgia, 30144
Simply Smiles Orthodontics
McKinney, Texas, 75070
Wolf/Chhibber Orthodontics
Norwalk, Ohio, 44857
Riolo Orthodontics
Seattle, Washington, 98101
Henseler Orthodontics
Woodbury, Minnesota, 55125
Horton Orthodontics
Woodbury, Minnesota, 55125
About this study
Official title: Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.
Read the detailed description
This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.
The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).
The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.
- Conditions
- Malocclusion
- Being tested
- Clear Aligner
- Keywords
- Aligners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear AlignerDevice
Also called 3M Clear Aligner
Clear Aligner used to straighten teeth to desired outcome
| Study group | Role | What they receive |
|---|---|---|
| 3M Clear Aligner | Other | Clear Aligner for Orthodontic Treatment Receives: Device: Clear Aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Correction of Malocclusion
Achievement of target setup per treatment plan as determined by Orthodontist.
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Secondary outcomes (11)
Individual Tooth Movement
Achievement of individual tooth movement measured per treatment plan and digital scan
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Treatment Time for Tooth Movement
Achievement of individual tooth movement measured per treatment plan
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Effective Use of Attachments
Effective use of attachment by tracking attachment bond failures by visual assessment
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Orthodontist Satisfaction
Orthodontist satisfaction with treatment outcome
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Software Satisfaction
Orthodontist satisfaction with treatment management software -Ease of use in ordering products
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Aligner Comfort
Aligner comfortable to wear
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Appearance Satisfaction
Subject satisfaction with appearance during treatment
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Aligner Ease of Cleaning
Subject satisfaction with ease of cleaning during treatment
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Ease of Insertion
Subject satisfaction with treatment; specifically aligners easy to insert
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Mid Course Corrections/Refinements Needed
Number of mid course refinements or corrections
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Ease of Aligner Removal
Subject satisfaction with treatment; specifically with aligner removal
Measured: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start30 Jan 2017
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum Orthodontics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Gail E Maxey, BA, CCRA, Study director, 3M Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141788
- Sponsor's protocol ID
- US-05-013821/11-050005
- Status last verified
- Nov 2024
- First submitted
- 27 Apr 2017
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
- ClinicalTrials.gov ID
- NCT03141788
- Acronym / sponsor ID
- US-05-013821/11-050005
- Conditions
- Malocclusion
- Keywords
- Aligners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Solventum Orthodontics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.
Detailed description
This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.
The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).
The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3M Clear Aligner | Other | Device: Clear AlignerClear Aligner for Orthodontic Treatment |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 14 years of age.
- Subject is willing and able to give informed consent.
- Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
- Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
- Subject has good oral hygiene defined by the orthodontist.
Key exclusion criteria (9 listed)
- Subject has skeletal discrepancies requiring surgery
- Subject is undergoing active dental work
- Subject has severe open bite > 2 mm
- Subject has severe overjet > 4 mm
- Subject has deep bite > 3 mm
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 |
|---|---|---|
| Clear AlignerAlso: 3M Clear AlignerClear Aligner used to straighten teeth to desired outcome | Device | 3M Clear Aligner |
Primary outcome
Successful Correction of Malocclusion
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Achievement of target setup per treatment plan as determined by Orthodontist.
11 secondary outcomes
Individual Tooth Movement
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Treatment Time for Tooth Movement
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Effective Use of Attachments
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Orthodontist Satisfaction
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Software Satisfaction
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Aligner Comfort
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Appearance Satisfaction
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Aligner Ease of Cleaning
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Ease of Insertion
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Mid Course Corrections/Refinements Needed
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Ease of Aligner Removal
Time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
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Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
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FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
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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.
Gail E Maxey, BA, CCRA study director
3M Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligner in people with Malocclusion, run by Solventum Orthodontics Corporation at 9 sites in United States.
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 6 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 4 Nov 2020). 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?
Successful Correction of Malocclusion (time frame: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 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 2 Dec 2024.