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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Clear Aligner used to straighten teeth to desired outcome
Benson Orthodontics
Denver, Colorado, United States
Depew Orthodontics
Kennesaw, Georgia, United States
Orthodontics Associates
Catonsville, Maryland, United States
Henseler Orthodontics
Woodbury, Minnesota, United States
Successful Correction of Malocclusion
Achievement of target setup per treatment plan as determined by Orthodontist.
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.
Individual Tooth Movement
Achievement of individual tooth movement measured per treatment plan and digital scan
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
Achievement of individual tooth movement measured per treatment plan
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
Effective use of attachment by tracking attachment bond failures by visual assessment
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
Orthodontist satisfaction with treatment outcome
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
Orthodontist satisfaction with treatment management software -Ease of use in ordering products
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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
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
Aligner comfortable to wear
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
Subject satisfaction with appearance during treatment
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
Subject satisfaction with ease of cleaning during treatment
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
Subject satisfaction with treatment; specifically aligners easy to insert
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
Number of mid course refinements or corrections
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
Subject satisfaction with treatment; specifically with 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.