PlaquePhase 3NCT07398846
Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
A Phase 3 study testing 0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste in people with Plaque, run by Colgate Palmolive at 1 site in United States.
Trial summary
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque
- What is being tested?
- 0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 29 Apr 2026
- 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 aged 18-70 years, inclusive.
- Availability for the twelve-week duration of the clinical research study.
- Good general health based on the opinion of the study investigator
- Minimum of 20 permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index.
Who cannot join
- Presence of orthodontic appliances;
- Presence of partial removable dentures;
- Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone);
- Five or more carious lesions requiring immediate restorative treatment;
- Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Use of antibiotics any time during the one-month period prior to entry into the study;
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- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome;
- Participation in any other clinical study;
- Self-reported pregnancy and/or breastfeeding;
- Dental prophylaxis within the past three weeks prior to baseline examinations;
- Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients;
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours;
- Current smokers and/or a history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Research Consulting, LLC
Melbourne, Florida, 32935
About this study
Official title: A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
- Conditions
- Plaque
- Being tested
- 0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste, 0.022% Sodium Fluoride mouthwash
- Keywords
- gingivitis
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454%Stannous fluoride toothpasteDrug
toothpaste
0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwasheDrug
mouthwash
0.76% Sodium Monofluorophosphate (Na MFP) toothpasteDrug
toothpaste
0.022% Sodium Fluoride mouthwashDrug
mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided Receives: Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe |
| Test 2 | Experimental | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided Receives: Drug: 0.454%Stannous fluoride toothpaste; Drug: 0.022% Sodium Fluoride mouthwash |
| Test 3 | Active comparator | instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided Receives: Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: 0.022% Sodium Fluoride mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loe-Silness Gingival Index
score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces
Measured: Baseline, 6-weeks, and 12-weeks
Rustogi Modification of the Navy Plaque Index
a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating.
Measured: Baseline, 6-weeks, and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start26 Jan 2026
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlaqueStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398846
- Sponsor's protocol ID
- CRO-2025-05-PG-BTB-FL-BGS
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
- ClinicalTrials.gov ID
- NCT07398846
- Acronym / sponsor ID
- CRO-2025-05-PG-BTB-FL-BGS
- Conditions
- Plaque
- Keywords
- gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 10 Feb 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.
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Drug: 0.454%Stannous fluoride toothpaste, Drug: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwasheinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided |
| Test 2 | Experimental | Drug: 0.454%Stannous fluoride toothpaste, Drug: 0.022% Sodium Fluoride mouthwashinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided |
| Test 3 | Active comparator | Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste, Drug: 0.022% Sodium Fluoride mouthwashinstructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form.
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the twelve-week duration of the clinical research study.
- Good general health based on the opinion of the study investigator
- Minimum of 20 permanent natural teeth (excluding third molars).
Key exclusion criteria (13 listed)
- Presence of orthodontic appliances;
- Presence of partial removable dentures;
- Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity; 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone);
- Five or more carious lesions requiring immediate restorative treatment;
- Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
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 |
|---|---|---|
| 0.454%Stannous fluoride toothpastetoothpaste | Drug | Test 1, Test 2 |
| 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashemouthwash | Drug | Test 1 |
| 0.76% Sodium Monofluorophosphate (Na MFP) toothpastetoothpaste | Drug | Test 3 |
| 0.022% Sodium Fluoride mouthwashmouthwash | Drug | Test 2, Test 3 |
Primary outcome
Loe-Silness Gingival Index
Time frame: Baseline, 6-weeks, and 12-weeks
score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces
Rustogi Modification of the Navy Plaque Index
Time frame: Baseline, 6-weeks, and 12-weeks
a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating.
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 22 May 2026.
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Enrolling by invitation
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 0.454%Stannous fluoride toothpaste, 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste in people with Plaque, 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 7 inclusion and 13 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 22 May 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. 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?
Loe-Silness Gingival Index (time frame: Baseline, 6-weeks, and 12-weeks). The study lists 2 primary outcomes in all. 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 22 May 2026.