Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-01-30
2019-10-09
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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3M Clear Aligner
Clear Aligner for Orthodontic Treatment
Clear Aligner
Clear Aligner used to straighten teeth to desired outcome
Interventions
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Clear Aligner
Clear Aligner used to straighten teeth to desired outcome
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is willing and able to give informed consent.
3. Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
4. Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
5. Subject has good oral hygiene defined by the orthodontist.
6. Subject has only permanent dentition.
Exclusion Criteria
2. Subject is undergoing active dental work
3. Subject has severe open bite \> 2 mm
4. Subject has severe overjet \> 4 mm
5. Subject has deep bite \> 3 mm
6. Subject has over crowding per arch \> 4 mm
7. Subject has dental prostheses/implants that will interfere with projected teeth movement
8. Subject is taking systemic steroid medication
9. Subject is taking Biphosphonates or any other medication for treatment of osteoporosis
14 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Solventum Orthodontics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gail E Maxey, BA, CCRA
Role: STUDY_DIRECTOR
3M Company
Locations
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Benson Orthodontics
Denver, Colorado, United States
Depew Orthodontics
Kennesaw, Georgia, United States
Orthodontics Associates
Catonsville, Maryland, United States
Henseler Orthodontics
Woodbury, Minnesota, United States
Horton Orthodontics
Woodbury, Minnesota, United States
Mellion Orthodontics
Fairlawn, Ohio, United States
Wolf/Chhibber Orthodontics
Norwalk, Ohio, United States
Simply Smiles Orthodontics
McKinney, Texas, United States
Riolo Orthodontics
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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US-05-013821/11-050005
Identifier Type: -
Identifier Source: org_study_id