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Completed

NCT Number: NCT06800443

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.

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Key information

Conditions

Tooth Color

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SPRIM China

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Silica-based fluoride toothpaste with blue covarine

Other

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

Control silica-based fluoride toothpaste

Other

Control silica-based toothpaste containing fluoride as sodium fluoride

Primary outcomes

  1. Tooth whiteness index (WIO) (average value from two upper central incisors

    Time frame: Immediately after brushing

    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.

Secondary outcomes

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

    Time frame: Immediately after brushing

    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.

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

    Time frame: Immediately after brushing

    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.

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

    Time frame: Immediately after brushing

    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.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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