Evaluation of Clear Aligner Trays to Straighten Teeth
- Conditions
- Malocclusion
- Interventions
- Device: Clear Aligner
- Registration Number
- NCT03141788
- Lead Sponsor
- Solventum Orthodontics Corporation
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3M Clear Aligner Clear Aligner Clear Aligner for Orthodontic Treatment
- Primary Outcome Measures
Name Time Method Successful Correction of Malocclusion 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.
- Secondary Outcome Measures
Name Time Method Individual Tooth Movement 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 individual tooth movement measured per treatment plan and digital scan
Ease of Insertion 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. Subject satisfaction with treatment; specifically aligners easy to insert
Aligner Comfort 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 comfortable to wear
Effective Use of Attachments 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 attachment by tracking attachment bond failures by visual assessment
Aligner Ease of Cleaning 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. Subject satisfaction with ease of cleaning during treatment
Mid Course Corrections/Refinements Needed 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. Number of mid course refinements or corrections
Treatment Time for Tooth Movement 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 individual tooth movement measured per treatment plan
Orthodontist Satisfaction 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 with treatment outcome
Software Satisfaction 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 with treatment management software -Ease of use in ordering products
Appearance Satisfaction 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. Subject satisfaction with appearance during treatment
Ease of Aligner Removal 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. Subject satisfaction with treatment; specifically with aligner removal
Trial Locations
- Locations (9)
Depew Orthodontics
🇺🇸Kennesaw, Georgia, United States
Riolo Orthodontics
🇺🇸Seattle, Washington, United States
Simply Smiles Orthodontics
🇺🇸McKinney, Texas, United States
Benson Orthodontics
🇺🇸Denver, Colorado, United States
Orthodontics Associates
🇺🇸Catonsville, Maryland, United States
Henseler Orthodontics
🇺🇸Woodbury, Minnesota, United States
Mellion Orthodontics
🇺🇸Fairlawn, Ohio, United States
Horton Orthodontics
🇺🇸Woodbury, Minnesota, United States
Wolf/Chhibber Orthodontics
🇺🇸Norwalk, Ohio, United States