Primer Aligner Study - CSP-300307-02 - Rev. B
Research type
Research Study
Full title
Primer Aligner Study
IRAS ID
178743
Contact name
Allison Mossing
Contact email
Sponsor organisation
Align Technology, Inc.
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. Each aligner is worn for about 2 weeks, then replaced by the next in the series until the final position is achieved.
In this study, 2 limited aligner options and primer aligners will also be used. Primer aligners are defined as 3 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.Approximately 40 patients (total 240 patients) are planned. Two treatment cohorts will be used as follow:
7Aligner cohort:
-Control Group (7 Aligners, no primer aligner)
-Test group 1 (7 Aligner + Primer Aligners,2week wear)
-Test group 2 (7 Aligner +Primer Aligners,1week wear)
12Aligner cohort:
-Control Group (12 aligners, no primer aligner)
-Test group 3(12 Aligner +Primer Aligners,2week wear)
-Test group 4(12 Aligner +Primer Aligners,1week wear)Each patient will be in this study for approximately 3-7 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 and be indicated for Invisalign treatment.
REC name
West of Scotland REC 3
REC reference
15/WS/0152
Date of REC Opinion
20 Aug 2015
REC opinion
Further Information Favourable Opinion