Tooth WhiteningPhase 2NCT07870018
Clinical Research Study to Evaluate Stain Removal and Whitening Improvement
A Phase 2 study testing Vitamin C toothpaste in people with Tooth Whitening and Tooth Discoloration, run by Colgate Palmolive at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Whitening, Tooth Discoloration
- What is being tested?
- Vitamin C toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 18 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Research Consulting, LLC
Melbourne, Florida, 32940
About this study
Official title: Clinical Research Study to Evaluate Stain Removal and Whitening Improvement of a Toothpaste Containing Vitamin C as Compared to a Matching Placebo Toothpaste After 6-weeks of Product Use
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
- Conditions
- Tooth Whitening, Tooth Discoloration
- Being tested
- Vitamin C toothpaste, Matching placebo
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C toothpasteDrug
1 .5 % 2-phospho-L- ascorbic acid, 1100ppm Sodium Fluoride (NaF )
Matching placeboDrug
0 % 2- phospho-L-ascorbic acid, 1100ppm Sodium Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Brush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste Receives: Drug: Vitamin C toothpaste |
| Test 2 toothpaste | Placebo comparator | Brush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 1 week, 3 week, 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start4 Nov 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WhiteningStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Gallob, DMD, Principal investigator, President /Owner Consumer Research Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870018
- Sponsor's protocol ID
- CRO-2021-10-STAWHT-VIC-FL-BGS
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Evaluate Stain Removal and Whitening Improvement of a Toothpaste Containing Vitamin C as Compared to a Matching Placebo Toothpaste After 6-weeks of Product Use
- ClinicalTrials.gov ID
- NCT07870018
- Acronym / sponsor ID
- CRO-2021-10-STAWHT-VIC-FL-BGS
- Conditions
- Tooth Whitening, Tooth Discoloration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: Vitamin C toothpasteBrush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste |
| Test 2 toothpaste | Placebo comparator | Drug: Matching placeboBrush your teeth twice daily (morning and evening ) for two (2 ) minutes each time. Cover the entire length of the bristled head with toothpaste |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C toothpaste1 .5 % 2-phospho-L- ascorbic acid, 1100ppm Sodium Fluoride (NaF ) | Drug | Test 1 toothpaste |
| Matching placebo0 % 2- phospho-L-ascorbic acid, 1100ppm Sodium Fluoride | Drug | Test 2 toothpaste |
Primary outcome
Interproximal Modified Lobene (IML ) Stain Index
Time frame: Baseline, 1 week, 3 week, 6 week
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
1 secondary outcome
Vita Extended Bleachedguide 3D-Master®
Time frame: Baseline, 1 week, 3 week, 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gallob, DMD principal investigator
President /Owner Consumer Research Consulting, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C toothpaste in people with Tooth Whitening and Tooth Discoloration, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interproximal Modified Lobene (IML ) Stain Index (time frame: Baseline, 1 week, 3 week, 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.