Evaluation of Clear Aligner Trays to Straighten Teeth

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141788
• Other study ID #: US-05-013821/11-050005
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: October 9, 2019

Study information

• Verified date: November 2020
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Clear Aligner
Clear Aligner used to straighten teeth to desired outcome

Locations

Country	Name	City	State
United States	Orthodontics Associates	Catonsville	Maryland
United States	Benson Orthodontics	Denver	Colorado
United States	Mellion Orthodontics	Fairlawn	Ohio
United States	Depew Orthodontics	Kennesaw	Georgia
United States	Simply Smiles Orthodontics	McKinney	Texas
United States	Wolf/Chhibber Orthodontics	Norwalk	Ohio
United States	Riolo Orthodontics	Seattle	Washington
United States	Henseler Orthodontics	Woodbury	Minnesota
United States	Horton Orthodontics	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.