NCT02151058 is a NA clinical trial of Colgate® Regular Cavity Protection in Tooth Stain, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.

Who is sponsoring NCT02151058?

NCT02151058 is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.

What drugs are being tested in NCT02151058?

Interventions in NCT02151058: Colgate® Regular Cavity Protection, Experimental Mouth Rinse, Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint.

What condition does NCT02151058 study?

NCT02151058 studies Tooth Stain.

Is NCT02151058 still recruiting?

NCT02151058 is currently completed. Last updated 28 May 2015.

Are results published for NCT02151058?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-05-28 · How we verify

NCT02151058

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial

Completed NA Results posted Last updated 28 May 2015

What this trial tests

NA trial testing Colgate® Regular Cavity Protection in Tooth Stain in 227 participants. Completed in 1 July 2014.

Timeline

1 June 2014

Primary endpoint
1 July 2014

1 July 2014

Quick facts

Lead sponsor	Johnson & Johnson Consumer and Personal Products Worldwide
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Enrollment	227
Start date	1 June 2014
Primary completion	1 July 2014
Estimated completion	1 July 2014
Sites	1 location across United States

Drugs / interventions tested

Colgate® Regular Cavity Protection — full drug profile →
Experimental Mouth Rinse — full drug profile →
Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint

Conditions studied

Tooth Stain — all drugs for Tooth Stain →

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide — full company profile →

Who can join

Adults 18 to 65, any sex, with Tooth Stain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Lobene Stain Index Composite Score at Day 15
Time frame: 15 Days
Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering \> 1/3 to 2/3 of the region and 3 =

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Home-based chemically-induced whitening (bleaching) of teeth in adults.
Eachempati P, Kumbargere Nagraj S, Kiran Kumar Krishanappa S, Gupta P, et al · · 2018 · cited 19× · PMID 30562408 · DOI 10.1002/14651858.cd006202.pub2

Verify or expand the search:

Other Johnson & Johnson Consumer and Personal Products Worldwide trials

Trials by the same sponsor.

NCT06798441 — Determination of the Oral Irritation Potential of a Fluoride Rinse in Children · NA · completed
NCT06479096 — Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash · NA · completed
NCT07028671 — Exploratory Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms · completed
NCT03213353 — A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms · Phase 1 · completed
NCT03041064 — Multiday Beach Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02151058 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Consumer and Personal Products Worldwide
Last refreshed: 28 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02151058.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing