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CompletedNCT07870018Updated Oct 13, 2026

Clinical Research Study to Evaluate Stain Removal and Whitening Improvement

A Phase 2 interventional study of Vitamin C toothpaste and Matching placebo in Tooth Whitening and Tooth Discoloration, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Colgate Palmolive · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2021, 4 years 10 months ago, and no results have been posted to the registry.
  • Registered 4 years 11 months after the study started (first participant enrolled Nov 2021, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The objective of this clinical research study is to evaluate the stain removal and whitening improvement of a toothpaste containing Vitamin C and 1100 ppm F as sodium fluoride as compared to a matching placebo toothpaste (identically formulated without Vitamin C ) in adults

02

Conditions studied

  • Tooth Whitening
  • Tooth Discoloration

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03

In context

Tooth Discoloration

107 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 75 is above the median of 46 across 99 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed Informed Consent Form;
  • Male and female subjects, aged 18-70, inclusive;
  • Good general health and good oral health based on the opinion of the study investigator;
  • Presence of all permanent natural anterior teeth (no veneers /crowns /restorations that may interfere with this study scoring procedures );
  • A minimum mean of 1 .5 ≥ determined by the Interproximal Modified Lobene (IML ) Stain Index;
  • Minimum average VITA 3D-Master Extended Bleachedguide shade score of 17 ≥ or darker;
  • Available for the duration of the study;
  • Clinical evidence of a tendency to form extrinsic stain on anterior teeth

Exclusion criteria

Exclusion Criteria:

  • Presence of orthodontic appliances /retainers involving scorable teeth;
  • Presence of partial removable /fixed dentures and /or restorations involving scorable teeth;
  • Tumor (s ) of the soft or hard tissues of the oral cavity;
  • Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
  • Five or more carious lesions requiring immediate care;
  • Use of antibiotics, stain-inducing medications, and /or on any prescription that might interfere with the study outcome;
  • Concurrent participation in another clinical study;
  • Self-reported pregnancy and /or lactating women;
  • Have used professional whitening product within one (1 ) year or had a dental prophylaxis (professional dental cleaning ) within thirty (30 ) days - prior to the start of the study;
  • History of allergies to oral care /personal care consumer products or their ingredients;
  • History of alcohol and /or drug abuse.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Test 1 toothpaste

    Brush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste

    Drug: Vitamin C toothpaste

  • Placebo comparator
    Test 2 toothpaste

    Brush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste

    Drug: Matching placebo

Interventions

  • DrugVitamin C toothpaste

    1 .5 % 2-phospho-L- ascorbic acid, 1100ppm Sodium Fluoride (NaF )

  • DrugMatching placebo

    0 % 2- phospho-L-ascorbic acid, 1100ppm Sodium Fluoride

06

What researchers measure

Primary outcomes

  1. Interproximal Modified Lobene (IML ) Stain Index

    Stain reduction determined by examiner via the Interproximal Modified Lobene (IML ). A minimum mean of 1 .5 ≥ determined by the Interproximal Modified Lobene (IML ) Stain Index; Stain Index

    Time frame: Baseline, 1 week, 3 week, 6 week

Secondary outcomes

  1. Vita Extended Bleachedguide 3D-Master®

    Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master® (29 tabs ). Minimum average VITA 3D-Master Extended Bleachedguide shade score of 17 ≥ or darker

    Time frame: Baseline, 1 week, 3 week, 6 week

07

Study locations

1 site
  • Consumer Research Consulting, LLC
    Melbourne, Florida 32940, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870018
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Nov 4, 2021
Primary completion
Dec 18, 2021
Completion
Dec 18, 2021
Last update
Oct 13, 2026

Study contacts

John Gallob, DMD
principal investigator · President /Owner Consumer Research Consulting, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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