A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth
rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days
compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest®
3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed
toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to
compare to brushing alone.
225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be
in this study will have an equal chance of being assigned to one of the three treatment
groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline
3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of
use). Volunteers will maintain a diary at home to record each treatment use. Examinations for
oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with
water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5,
which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).
Phase:
N/A
Details
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide