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

NCT06800443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • Tooth Color

Interventions

OTHER

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

OTHER

Silica-based fluoride toothpaste with blue covarine

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

OTHER

Silica-based fluoride toothpaste with blue covarine

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

OTHER

Control silica-based fluoride toothpaste

Control silica-based toothpaste containing fluoride as sodium fluoride

Sponsors & Collaborators

  • Unilever R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-01-04
Completion
2019-01-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800443 on ClinicalTrials.gov