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A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control
Sponsor: Unilever R&D
Summary
This will be a double blind, randomised, four-group crossover study. This study will involve 5 visits to the study site, with a wash-out period of 1 week between visits. Visit 1 will be for screening, participants who meet inclusion and exclusion criteria (including having Vita shade score of 2M2, 3R1.5, 2R2.5, 3L1.5, 2L2.5, 4M1, 2M3, 3M2, 4R1.5, 4L1.5, 3L2.5, 3R2.5, 5M1, 4M2, 3M3 from VITA 3D-MASTER Shade Guide) will be accepted onto the study. At each test visit (visit 2 - 5), participants will have images taken of their front upper incisors using a a Video-based Digital Imaging System (VDIS) pre- and post-brushing with randomly allocated test or control toothpaste \[1.5g for 90 seconds, followed by water rinse\]. The digital images will be analysed using the VDIS image analysis software and the mean CIELAB and WIO of the upper central incisors will be obtained.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2018-12-03
Completion Date
2019-01-04
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine
Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
Silica-based fluoride toothpaste with blue covarine
Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate
Silica-based fluoride toothpaste with blue covarine
Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate
Control silica-based fluoride toothpaste
Control silica-based toothpaste containing fluoride as sodium fluoride
Locations (1)
SPRIM China
Shanghai, China