An interventional study of Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine and Silica-based fluoride toothpaste with blue covarine in Tooth Color, sponsored by Unilever R&D. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Unilever R&D (part of Unilever) · Not applicable, Interventional, and Treatment
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.
Unilever R&D is the lead sponsor of 71 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
Other: Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine
Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate
Other: Silica-based fluoride toothpaste with blue covarine
Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate
Other: Silica-based fluoride toothpaste with blue covarine
Control silica-based toothpaste containing fluoride as sodium fluoride
Other: Control silica-based fluoride toothpaste
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
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
Plan to share: No — Participant consent not available for this type of sharing.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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