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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test toothpaste 1 | Experimental | Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride |
|
| Test toothpaste 2 | Experimental | Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate |
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| Test toothpaste 3 | Experimental | Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate |
|
| Control toothpaste | Other | Control silica-based toothpaste containing fluoride as sodium fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine | Other | Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after brushing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPRIM China | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40834827 | Derived | Zhang L, Joiner A, Gupta AK, Barili M, Platten S, McDonald MD, Luo W, Matheson JR. Effect of Blue Covarine Toothpastes on Tooth Colour: A Randomised Crossover Study. Int Dent J. 2025 Oct;75(5):100938. doi: 10.1016/j.identj.2025.100938. Epub 2025 Aug 19. |
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Participant consent not available for this type of sharing.
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| Silica-based fluoride toothpaste with blue covarine | Other | Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate |
|
| Silica-based fluoride toothpaste with blue covarine | Other | Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate |
|
| Control silica-based fluoride toothpaste | Other | Control silica-based toothpaste containing fluoride as sodium fluoride |
|
| 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. | 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. | Immediately after brushing |
| ID | Term |
|---|---|
| D002606 | Charcoal |
| C532297 | blue covarine |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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