A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control

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 Overview

• Status: Completed
• Conditions: Tooth Color
• Intervention / Treatment: Other: Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine; Other: Silica-based fluoride toothpaste with blue covarine; Other: Silica-based fluoride toothpaste with blue covarine; Other: Control silica-based fluoride toothpaste

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • SPRIM China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Two upper central incisors must be natural.
• The two upper central incisors must be within the colours 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.
• The two upper central incisors must be free of intrinsic stain e.g. caused by tetracycline, fluorosis etc.
• The two upper central incisors must be extrinsic stain free.
• Willing to sign an informed consent form and complete a medical history questionnaire.

Exclusion Criteria:

• Two upper central incisors have any caps, crowns, veneers or cracks in the teeth, have excessive gum recession, or have restorations on the distal, mesial, buccal, incisor edge in the opinion of the dentist and technician.
• Smoker (including e-cigarettes) or chews tobacco.
• Are diabetic
• Currently pregnant or breast feeding.
• Currently having orthodontics bands, partial removable dentures.
• Currently experiencing severe oral problems such as untreated caries, gingivitis or periodontal disease.
• Regular use of medication, which in the opinion of the study dentist, could interfere with study objectives.
• Known allergies to the toothpaste ingredients or to any dental materials.
• Use of tooth bleaching products in the past 6 months.
• Have been using whitening oral care products in the last 12 weeks or had a scale and polish in the last 3 months.
• Have or have had a medical condition that in the opinion of the study dentist would make them unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test toothpaste 1; 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 charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
Experimental: Test toothpaste 2; Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate	Other: Silica-based fluoride toothpaste with blue covarine; Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate; Other: Silica-based fluoride toothpaste with blue covarine; Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate
Experimental: Test toothpaste 3; Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate	Other: Silica-based fluoride toothpaste with blue covarine; Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate; Other: Silica-based fluoride toothpaste with blue covarine; Silica-based toothpaste containing higher level blue covarine and fluoride as sodium monofluorophosphate
Other: Control toothpaste; Control silica-based toothpaste containing fluoride as sodium fluoride	Other: Control silica-based fluoride toothpaste; Control silica-based toothpaste containing fluoride as sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Unilever R&D

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Antidotes; Cariostatic Agents; Fluorides; Charcoal
• Other Study ID Numbers: ORL-WHI-3378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant consent not available for this type of sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No