Clinical trial NCT06800443: A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control
Official title: A Cosmetic Study to Measure the Change in Tooth Colour After Using Instant Whitening Prototypes Compared to a Negative Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Color
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tooth whiteness index (WIO) (average value from two upper central incisors
timeFrame: Immediately after brushing
Secondary outcomes:
measure: Tooth Color Lightness L* (average value from two upper central incisors)
timeFrame: Immediately after brushing
measure: Tooth Color a* (red/green) (average value of two upper central incisors)
timeFrame: Immediately after brushing
measure: Tooth Color b* (blue/yellow) (average of two upper central incisors)
timeFrame: Immediately after brushing
Other outcomes:
Locations:
city: Shanghai
country: China
facility: SPRIM China
Study officials:
References: