Evaluation of Clear Aligner Trays to Straighten Teeth

Conditions

Malocclusion

Keywords

Aligners

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.

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Interventions

DEVICEClear Aligner

Clear Aligner used to straighten teeth to desired outcome

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
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

Countries

United States

Participant flow

Pre-assignment details

Screen failures because they did not meet Inclusion/Exclusion criteria

Participants by arm

Arm	Count
3M Clear Aligner Clear Aligner Treatment Clear Aligner: Clear Aligner used to straighten teeth to desired outcome	52
Total	52

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1
Overall Study	Protocol Violation	3
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	3M Clear Aligner
Age, Continuous	34.1 years STANDARD_DEVIATION 10.28
Class type of malocclusion Class III Malocclusion	1 Participants
Class type of malocclusion Class II Malocclusion	12 Participants
Class type of malocclusion Class I Malocclusion	39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Previous orthodontic treatments No	20 Participants
Previous orthodontic treatments Yes	32 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) White	46 Participants
Region of Enrollment United States	52 participants
Sex: Female, Male Female	37 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 52
other Total, other adverse events	2 / 52
serious Total, serious adverse events	0 / 52