At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial
In Brief
A clinical study evaluating Colgate® Regular Cavity Protection, Experimental Mouth Rinse, and 1 other intervention for Tooth Stain. Completed, enrolled 227 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)
Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.
Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.