Evaluation of Clear Aligner Trays to Straighten Teeth

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.

• Clear Aligner (Device), also known as 3M Clear Aligner: Clear Aligner used to straighten teeth to desired outcome

Primary outcomes

• 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 outcomes

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Sex: All, ages: 14 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Subject is at least 14 years of age.
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:

1. Subject has skeletal discrepancies requiring surgery
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

Participant flow

Outcome results

• Successful Correction of Malocclusion (Primary), Count of participants, Participants: 3M Clear Aligner 32
• Individual Tooth Movement (Secondary)
• Treatment Time for Tooth Movement (Secondary), Median, days: 3M Clear Aligner 443 (14 to 853)
• Effective Use of Attachments (Secondary), Mean, Percentage of Attachment Bond Failure: 3M Clear Aligner 5.4 +/- 14.58
• Orthodontist Satisfaction (Secondary), Count of participants, Participants: 3M Clear Aligner 5
• Software Satisfaction (Secondary)
• Aligner Comfort (Secondary), Count of units, study visits: 3M Clear Aligner 24
• Appearance Satisfaction (Secondary), Count of units, study visits: 3M Clear Aligner 470
• Aligner Ease of Cleaning (Secondary), Count of units, study visits: 3M Clear Aligner 436
• Ease of Insertion (Secondary), Count of units, study visits: 3M Clear Aligner 364
• Mid Course Corrections/Refinements Needed (Secondary), Count of participants, Participants: 3M Clear Aligner 21
• Ease of Aligner Removal (Secondary), Count of units, study visit: 3M Clear Aligner 308

Adverse events

Time frame: Up to 28 months

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-04-19)

• Gail E Maxey, BA, CCRA, Study director, 3M Company