Clinical Trial: Evaluation of Clear Aligner Trays to Straighten Teeth

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

This is a prospective, multi-center study with a maximum duration of 24 months, 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 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.


Sponsor: 3M

Current Primary Outcome: Successful correction of malocclusion [ Time Frame: Up to 24 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: Up to 24 months ]
    Number of adverse events
  • Individual tooth movement [ Time Frame: Up to 24 months ]
    Achievement of individual tooth movement measured per treatment plan and digital scan
  • Treatment time for tooth movement [ Time Frame: Up to 24 months ]
    Achievement of individual tooth movement measured per treatment plan
  • Effective use of attachments [ Time Frame: Up to 24 months ]
    Achievement of individual tooth movement measured per treatment plan and bond failures
  • Orthodontist satisfaction with treatment outcome [ Time Frame: Up to 24 months ]
    Achievement of individual tooth movement measured per treatment plan
  • Orthodontist satisfaction with treatment management software [ Time Frame: Up to 24 months ]
    Ease of use in ordering products
  • Subject satisfaction with ease of wear during treatment [ Time Frame: Up to 24 months ]
    Aligner ease of wear
  • Subject satisfaction with appearance during treatment [ Time Frame: Up to 24 months ]
    Aligner appearance
  • Subject satisfaction with ease of cleaning during treatment [ Time Frame: Up to 24 months ]
    Aligner ease of cleaning
  • Subject satisfaction with treatment compliance [ Time Frame: Up to 24 months ]
    Percent of wear compliance
  • Mid Course refinements or corrections needed [ Time Frame: Up to 24 months ]
    Number of mid course refinements or corrections


Original Secondary Outcome: Same as current

Information By: 3M

Dates:
Date Received: April 27, 2017
Date Started: January 30, 2017
Date Completion: May 2019
Last Updated: May 3, 2017
Last Verified: May 2017