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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Tooth Color

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Test toothpaste 1

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Test toothpaste 2

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

Group Type EXPERIMENTAL

Silica-based fluoride toothpaste with blue covarine

Intervention Type OTHER

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

Test toothpaste 3

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

Group Type EXPERIMENTAL

Silica-based fluoride toothpaste with blue covarine

Intervention Type OTHER

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

Control toothpaste

Control silica-based toothpaste containing fluoride as sodium fluoride

Group Type OTHER

Control silica-based fluoride toothpaste

Intervention Type OTHER

Control silica-based toothpaste containing fluoride as sodium fluoride

Interventions

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

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

Intervention Type OTHER

Silica-based fluoride toothpaste with blue covarine

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

Intervention Type OTHER

Silica-based fluoride toothpaste with blue covarine

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

Intervention Type OTHER

Control silica-based fluoride toothpaste

Control silica-based toothpaste containing fluoride as sodium fluoride

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes