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Evaluation of Clear Aligner Trays to Straighten Teeth

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clear Aligner
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Aligners

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Benson Orthodontics
  • Depew Orthodontics
  • Orthodontics Associates
  • Henseler Orthodontics
  • Horton Orthodontics
  • Mellion Orthodontics
  • Wolf/Chhibber Orthodontics
  • Simply Smiles Orthodontics
  • Riolo Orthodontics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3M Clear Aligner

Arm Description

Clear Aligner for Orthodontic Treatment

Outcomes

Primary Outcome Measures

Successful Correction of Malocclusion
Achievement of target setup per treatment plan as determined by Orthodontist.

Secondary Outcome Measures

Individual Tooth Movement
Achievement of individual tooth movement measured per treatment plan and digital scan
Treatment Time for Tooth Movement
Achievement of individual tooth movement measured per treatment plan
Effective Use of Attachments
Effective use of attachment by tracking attachment bond failures by visual assessment
Orthodontist Satisfaction
Orthodontist satisfaction with treatment outcome
Software Satisfaction
Orthodontist satisfaction with treatment management software -Ease of use in ordering products
Aligner Comfort
Aligner comfortable to wear
Appearance Satisfaction
Subject satisfaction with appearance during treatment
Aligner Ease of Cleaning
Subject satisfaction with ease of cleaning during treatment
Ease of Insertion
Subject satisfaction with treatment; specifically aligners easy to insert
Mid Course Corrections/Refinements Needed
Number of mid course refinements or corrections
Ease of Aligner Removal
Subject satisfaction with treatment; specifically with aligner removal

Full Information

First Posted
April 27, 2017
Last Updated
November 9, 2020
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT03141788
Brief Title
Evaluation of Clear Aligner Trays to Straighten Teeth
Official Title
Evaluation of 3M Clear Aligner for Correction of Class I, II and III Malocclusion Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Aligners

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3M Clear Aligner
Arm Type
Other
Arm Description
Clear Aligner for Orthodontic Treatment
Intervention Type
Device
Intervention Name(s)
Clear Aligner
Other Intervention Name(s)
3M Clear Aligner
Intervention Description
Clear Aligner used to straighten teeth to desired outcome
Primary Outcome Measure Information:
Title
Successful Correction of Malocclusion
Description
Achievement of target setup per treatment plan as determined by Orthodontist.
Time Frame
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 Measure Information:
Title
Individual Tooth Movement
Description
Achievement of individual tooth movement measured per treatment plan and digital scan
Time Frame
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.
Title
Treatment Time for Tooth Movement
Description
Achievement of individual tooth movement measured per treatment plan
Time Frame
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.
Title
Effective Use of Attachments
Description
Effective use of attachment by tracking attachment bond failures by visual assessment
Time Frame
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.
Title
Orthodontist Satisfaction
Description
Orthodontist satisfaction with treatment outcome
Time Frame
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.
Title
Software Satisfaction
Description
Orthodontist satisfaction with treatment management software -Ease of use in ordering products
Time Frame
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.
Title
Aligner Comfort
Description
Aligner comfortable to wear
Time Frame
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.
Title
Appearance Satisfaction
Description
Subject satisfaction with appearance during treatment
Time Frame
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.
Title
Aligner Ease of Cleaning
Description
Subject satisfaction with ease of cleaning during treatment
Time Frame
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.
Title
Ease of Insertion
Description
Subject satisfaction with treatment; specifically aligners easy to insert
Time Frame
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.
Title
Mid Course Corrections/Refinements Needed
Description
Number of mid course refinements or corrections
Time Frame
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.
Title
Ease of Aligner Removal
Description
Subject satisfaction with treatment; specifically with aligner removal
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail E Maxey, BA, CCRA
Organizational Affiliation
3M Company
Official's Role
Study Director
Facility Information:
Facility Name
Benson Orthodontics
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209-3244
Country
United States
Facility Name
Depew Orthodontics
City
Kennesaw
State/Province
Georgia
ZIP/Postal Code
30144
Country
United States
Facility Name
Orthodontics Associates
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Henseler Orthodontics
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Horton Orthodontics
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Mellion Orthodontics
City
Fairlawn
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Facility Name
Wolf/Chhibber Orthodontics
City
Norwalk
State/Province
Ohio
ZIP/Postal Code
44857
Country
United States
Facility Name
Simply Smiles Orthodontics
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Riolo Orthodontics
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Clear Aligner Trays to Straighten Teeth

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