WhiteningPhase 3NCT06957249
Clinical Study to Evaluate the Tooth Whitening Efficacy
A Phase 3 study testing Optic White 5%HP ActivShine Toothpaste and Crest3DWhite Advanced Radiant Mint Toothpaste in people with Whitening, run by Colgate Palmolive at 1 site in United States.
Trial summary
Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Whitening
- What is being tested?
- Optic White 5%HP ActivShine Toothpaste and Crest3DWhite Advanced Radiant Mint Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2025to 5 May 2025
- Phase
- Phase 3
- 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 18-70 years old, inclusive;
- Good general health and good oral health based on the opinion of the study investigator;
- All maxillary natural permanent anterior teeth (6-11) must be present;
- Availability for the duration of the study;
- Minimum average Vita Extended Bleachedguide 3D-Master shade score of 17 ≥ or darker.
Who cannot join
- Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
- 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;
- Concurrent participation in another clinical study;
- Self-reported pregnant and/or lactating women;
- History of allergies or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
- Restorations on the teeth to be scored which may interfere with scoring procedures;
- Have used a professional whitening product within one (1) year and/or had a dental prophylaxis (professional dental cleaning) within thirty (30) days prior to the start of the study
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 Study to Evaluate the Tooth Whitening Efficacy of a Colgate Toothpaste With 5% Hydrogen Peroxide and Fluoride Compared to a Toothpaste With 0% Hydrogen Peroxide and Fluoride Over a One-Week Period.
Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.
- Conditions
- Whitening
- Being tested
- Optic White 5%HP ActivShine Toothpaste, Crest3DWhite Advanced Radiant Mint Toothpaste
- Keywords
- hydrogen peroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic White 5%HP ActivShine ToothpasteDrug
0.76% MFP toothpaste
Crest3DWhite Advanced Radiant Mint ToothpasteDrug
0.243% NaF toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test 1 Toothpaste | Experimental | fluoride toothpaste Receives: Drug: Optic White 5%HP ActivShine Toothpaste |
| Test 2 Toothpaste | Active comparator | fluoride toothpaste Receives: Drug: Crest3DWhite Advanced Radiant Mint Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color measurement
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master® (29 tabs)
Measured: baseline, day 1, day 3, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start25 Apr 2025
- Primary completion3 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WhiteningStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Gallob, DMD, Principal investigator, Consumer Research Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957249
- Sponsor's protocol ID
- CRO-2025-04-WHT-5OW-FL-BGS
- Status last verified
- May 2025
- First submitted
- 26 Apr 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Tooth Whitening Efficacy of a Colgate Toothpaste With 5% Hydrogen Peroxide and Fluoride Compared to a Toothpaste With 0% Hydrogen Peroxide and Fluoride Over a One-Week Period.
- ClinicalTrials.gov ID
- NCT06957249
- Acronym / sponsor ID
- CRO-2025-04-WHT-5OW-FL-BGS
- Conditions
- Whitening
- Keywords
- hydrogen peroxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 4 May 2025 (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.
Optic White 5%HP ActivShine TP vs Crest3D White TP (head-to-head whitening clinical) The objective of this study is to evaluate the tooth whitening efficacy of a Colgate toothpaste with 5% Hydrogen Peroxide and Fluoride compared to a toothpaste with 0% Hydrogen Peroxide and Fluoride over a one-week period.
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: Optic White 5%HP ActivShine Toothpastefluoride toothpaste |
| Test 2 Toothpaste | Active comparator | Drug: Crest3DWhite Advanced Radiant Mint Toothpastefluoride toothpaste |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form;
- Male and female subjects 18-70 years old, inclusive;
- Good general health and good oral health based on the opinion of the study investigator;
- All maxillary natural permanent anterior teeth (6-11) must be present;
- Availability for the duration of the study;
Key exclusion criteria (8 listed)
- Presence of orthodontic appliances and/or any anterior tooth with a prosthetic crown, veneer, or deemed non-vital;
- 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;
- Concurrent participation in another clinical study;
- Self-reported pregnant and/or lactating women;
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 |
|---|---|---|
| Optic White 5%HP ActivShine Toothpaste0.76% MFP toothpaste | Drug | Test 1 Toothpaste |
| Crest3DWhite Advanced Radiant Mint Toothpaste0.243% NaF toothpaste | Drug | Test 2 Toothpaste |
Primary outcome
Tooth color measurement
Time frame: baseline, day 1, day 3, day 7
Changes in Tooth color determined by examiner use of Vita Extended Bleachedguide 3D-Master® (29 tabs)
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 3 Sep 2025.
- 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
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 3 study testing Optic White 5%HP ActivShine Toothpaste and Crest3DWhite Advanced Radiant Mint Toothpaste in people with Whitening, 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 6 inclusion and 8 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 3 Sep 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Tooth color measurement (time frame: baseline, day 1, day 3, day 7). 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 3 Sep 2025.