AzTrials
AzTrials

Tooth ColorNCT06800443

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

A study testing Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine and Silica-based fluoride toothpaste with blue covarine in people with Tooth Color, run by Unilever R&D at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Color
What is being tested?
Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine and Silica-based fluoride toothpaste with blue covarine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
3 Dec 2018to 4 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • SPRIM China

    Shanghai

Other trials in China

About this study

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
Being tested
Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine, Silica-based fluoride toothpaste with blue covarine, Control silica-based fluoride toothpaste

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarineOther

    Silica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride

  • Silica-based fluoride toothpaste with blue covarineOther

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

  • Silica-based fluoride toothpaste with blue covarineOther

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

  • Control silica-based fluoride toothpasteOther

    Control silica-based toothpaste containing fluoride as sodium fluoride

Study groups in NCT06800443
Study groupRoleWhat they receive
Test toothpaste 1ExperimentalSilica-based toothpaste containing charcoal, clay, blue covarine, green covarine and fluoride as sodium fluoride
Receives: Other: Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine
Test toothpaste 2ExperimentalSilica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate
Receives: Other: Silica-based fluoride toothpaste with blue covarine
Test toothpaste 3ExperimentalSilica-based toothpaste containing blue covarine and fluoride as sodium monofluorophosphate
Receives: Other: Silica-based fluoride toothpaste with blue covarine
Control toothpasteOtherControl silica-based toothpaste containing fluoride as sodium fluoride
Receives: Other: Control silica-based fluoride toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after brushing

Secondary outcomes (3)

  1. 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.

    Measured: Immediately after brushing

  2. 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.

    Measured: Immediately after brushing

  3. 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.

    Measured: Immediately after brushing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start3 Dec 2018
  3. Primary completion4 Jan 2019
  4. Study completion4 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800443
Sponsor's protocol ID
ORL-WHI-3378
Status last verified
Jan 2025
First submitted
13 Jan 2025
Last updated
17 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participant consent not available for this type of sharing.

Publications

  • 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.

    PubMed 40834827

Questions about this trial

What is this clinical trial studying?

A study testing Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine and Silica-based fluoride toothpaste with blue covarine in people with Tooth Color, run by Unilever R&D at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tooth whiteness index (WIO) (average value from two upper central incisors (time frame: Immediately after brushing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06800443, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in