Evaluation of Clear Aligner Trays to Straighten Teeth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Clear Aligner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3M Clear Aligner<br>Clear Aligner for Orthodontic Treatment | Device: Clear Aligner<br>* Clear Aligner used to straighten teeth to desired outcome<br>* Other names: 3M Clear Aligner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Correction of Malocclusion | Achievement of target setup per treatment plan as determined by Orthodontist. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Tooth Movement | Achievement of individual tooth movement measured per treatment plan and digital scan | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aligners