Primer Aligner Study - CSP-300307-02 - Rev. A

• Research type

  Research Study

• Full title

  Primer Aligner Study

• IRAS ID

  178743

• Contact name

  Whitney Huey

• Contact email

  whuey@aligntech.com

• Research summary

  The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. This is a custom made medical device. Each aligner exerts gentle, continuous forces to move teeth from their original state to a final, treated state.

  In this study, two limited aligner options will be used. Primer aligners will also be used in this study. Primer aligners are defined as three copies of aligner set #1 on both the upper and lower arches. The first limited aligner treatment will offer 7 aligner sets, which can correct up to 2mm of crowding and 10 degrees of rotation. The second limited aligner treatment option will offer 12 aligner sets, which can correct up to 3-3.5mm of crowding and 20 degrees of rotation.

  The purpose of this study is to demonstrate that providing time for biological response allows successful achievement of clinical outcomes and subject satisfaction when using the Invisalign product. The additional time for biological response will be added through Primer Aligners.

  Six groups of approximately 40 patients (total of 240 patients) are planned in this study:
  • 7 Aligner Control Group
  • 12 Aligner Control Group
  • 7 Aligner Test Group with Primer Aligners and two week wear.
  • 12 Aligner Test Group with Primer Aligners and two week wear
  • 7 Aligner Test Group with Primer Aligners and one week wear
  • 12 Aligner Test Group with Primer Aligners and one week wear

  Each patient will be in this study for approximately 3 months - 7 months as this is the usual amount of time that a patient would visit his/her doctor to complete orthodontic treatment to have your teeth straightened.
  The eligible patients must be adults, have fully erupted dentition et be indicated for Invisalign treatment.

• REC name

  West of Scotland REC 3

• REC reference

  15/WS/0114

• Date of REC Opinion

  4 Jun 2015

• REC opinion

  Unfavourable Opinion