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

NCT06800443 | Completed

• 1 other identifier: ORL-WHI-3378
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Color

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tooth Color Lightness L* (average value from two upper central incisors)

  Immediately after brushing

• Tooth Color a* (red/green) (average value of two upper central incisors)

  Immediately after brushing

• Tooth Color b* (blue/yellow) (average of two upper central incisors)

  Immediately after brushing

Study Arms (4)

Test toothpaste 1

EXPERIMENTAL

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

Test toothpaste 2

EXPERIMENTAL

Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate

Other: Silica-based fluoride toothpaste with blue covarine

Test toothpaste 3

EXPERIMENTAL

Silica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate

Other: Silica-based fluoride toothpaste with blue covarine

Control toothpaste

OTHER

Control silica-based toothpaste containing fluoride as sodium fluoride

Other: Control silica-based fluoride toothpaste

Interventions

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

Test toothpaste 1

Silica-based fluoride toothpaste with blue covarine OTHER

Silica-based toothpaste containing lower level of blue covarine and fluoride as sodium monofluorophosphate

Test toothpaste 2

Control silica-based fluoride toothpaste OTHER

Control silica-based toothpaste containing fluoride as sodium fluoride

Control toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

SPRIM China

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 40834827 DERIVED

MeSH Terms

Interventions

Charcoal; blue covarine

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 30, 2025
• Study Start: December 3, 2018
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)