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

Unilever

Status: Completed

Conditions: Tooth Color

Treatments: Other: Silica-based fluoride toothpaste with blue covarine; Other: Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine; Other: Control silica-based fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT06800443

ORL-WHI-3378

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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68 participants in 4 patient groups

Test toothpaste 1

Experimental group

Description:

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

Treatment:

Other: Silica-based fluoride toothpaste containing clay, charcoal, blue covarine and green covarine

Test toothpaste 2

Experimental group

Description:

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

Treatment:

Other: Silica-based fluoride toothpaste with blue covarine

Other: Silica-based fluoride toothpaste with blue covarine

Test toothpaste 3

Experimental group

Description:

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

Treatment:

Other: Silica-based fluoride toothpaste with blue covarine

Other: Silica-based fluoride toothpaste with blue covarine

Control toothpaste

Other group

Description:

Control silica-based toothpaste containing fluoride as sodium fluoride

Treatment:

Other: Control silica-based fluoride toothpaste