Evaluation of Clear Aligner Trays to Straighten Teeth

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Clear Aligner

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80209-3244
      • Benson Orthodontics
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Depew Orthodontics
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Orthodontics Associates
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Henseler Orthodontics
    • Woodbury, Minnesota, United States, 55125
      • Horton Orthodontics
  • Ohio
    • Fairlawn, Ohio, United States, 44333
      • Mellion Orthodontics
    • Norwalk, Ohio, United States, 44857
      • Wolf/Chhibber Orthodontics
  • Texas
    • McKinney, Texas, United States, 75070
      • Simply Smiles Orthodontics
  • Washington
    • Seattle, Washington, United States, 98101
      • Riolo Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3M Clear Aligner; Clear Aligner for Orthodontic Treatment	Device: Clear Aligner; Clear Aligner used to straighten teeth to desired outcome; Other Names: 3M Clear Aligner

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Solventum Orthodontics Corporation
• Collaborators: 3M
• Investigators: Study Director: Gail E Maxey, BA, CCRA, 3M Company

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Aligners
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: US-05-013821/11-050005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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