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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate
Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate
Control silica-based toothpaste containing fluoride as sodium fluoride
SPRIM China
Shanghai, China
Tooth whiteness index (WIO) (average value from two upper central incisors
Digital images of the upper central incisors will be taken before and immediately after brushing with toothpaste using a Video-based Digital Imaging System (VDIS). WIO will be obtained from VDIS images\[1\]. The outcome measure per participant will be the average values from two upper central incisor teeth. Increase in WIO means whiter. \[1\] Luo, Wen et al. J Dent. 2017;67S:S15-S19.
Time frame: Immediately after brushing
Tooth Color Lightness L* (average value from two upper central incisors)
Digital images of the upper central incisors will be taken before and immediately after brushing with toothpaste using a Video-based Digital Imaging System (VDIS). L\* will be obtained from VDIS images\[1\]. L\* (Lightness) is one of the axes in CIELAB 3D color space. L\* axis runs vertically and represents the lightness of the color. It ranges from 0 (black) to 100 (white). An increase in L\* indicates tooth is lighter in color. \[1\] Luo, Wen et al. J Dent. 2017;67S:S15-S19.
Time frame: Immediately after brushing
Tooth Color a* (red/green) (average value of two upper central incisors)
Digital images of the upper central incisors will be taken before and immediately after brushing with toothpaste using a Video-based Digital Imaging System (VDIS). a\* will be obtained from VDIS images\[1\]. a\* (red-green) is one of the axes in CIELAB 3D color space. a\* axis runs horizontally and represents the color's position between red and green. Positive values indicate a shift towards red, while negative values indicate a shift towards green. \[1\] Luo, Wen et al. J Dent. 2017;67S:S15-S19.
Time frame: Immediately after brushing
Tooth Color b* (blue/yellow) (average of two upper central incisors)
Digital images of the upper central incisors will be taken before and immediately after brushing with toothpaste using a Video-based Digital Imaging System (VDIS). b\* will be obtained from VDIS images\[1\]. b\* (blue-yellow) is one of the axes in CIELAB 3D color space. The b\* axis runs horizontally and represents the color's position between blue and yellow. Positive values indicate a shift towards yellow, while negative values indicate a shift towards blue. \[1\] Luo, Wen et al. J Dent. 2017;67S:S15-S19.
Time frame: Immediately after brushing
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