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A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal

NCT02151058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2015-06-01

Study results available
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Summary

The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to compare to brushing alone.

225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline 3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of use). Volunteers will maintain a diary at home to record each treatment use. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).

Conditions

  • Tooth Stain

Interventions

DRUG

Colgate® Regular Cavity Protection

Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)

DRUG

Experimental Mouth Rinse

Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.

OTHER

Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint

Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Jeffery Milleman Milleman, DDS, MPA · Salus Research Inc.

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

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 NCT02151058 on ClinicalTrials.gov