A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
Public ClinicalTrials.gov record NCT02151058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02151058
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 227 participants
Conditions and interventions
Conditions
Interventions
- Colgate® Regular Cavity Protection Drug
- Experimental Mouth Rinse Drug
- Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2014
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- May 31, 2015
2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Salus Research Inc | Fort Wayne | Indiana | 46825 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02151058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 31, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02151058 live on ClinicalTrials.gov.