PlaquePhase 3NCT07917507
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
A Phase 3 study testing 0.412% stannous fluoride toothpaste and flat trimmed toothbrush and 0.76% Na MFP and flat trimmed toothbrush in people with Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Dominican Republic.
Trial summary
Clinical Research study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of 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, Gingivitis
- What is being tested?
- 0.412% stannous fluoride toothpaste and flat trimmed toothbrush and 0.76% Na MFP and flat trimmed toothbrush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDominican Republic
- Study dates
- 9 Oct 2026to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 24 weeks (6 months) 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 plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Who cannot join
- Presence of orthodontic appliances.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one-month period prior to entry into the study.
Show all 13Show fewer
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome.
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- History of alcohol and/or drug abuse.
- Self-reported pregnancy and/or lactating subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride and a Standard Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.
Clinical Research study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of established dental plaque and gingivitis
- Conditions
- Plaque, Gingivitis
- Being tested
- 0.412% stannous fluoride toothpaste and flat trimmed toothbrush, 0.76% Na MFP and flat trimmed toothbrush
- 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.
0.412% stannous fluoride toothpaste and flat trimmed toothbrushDrug
Brush with full ribbon, 2x day / 2mins
0.76% Na MFP and flat trimmed toothbrushDrug
Brush with full ribbon, 2x day / 2mins
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste | Experimental | 0.412% SnF Brush w/ full ribbon, 2x day / 2mins Receives: Drug: 0.412% stannous fluoride toothpaste and flat trimmed toothbrush; Drug: 0.76% Na MFP and flat trimmed toothbrush |
| toothpaste | Active comparator | 0.76% Na MFP, (1000 ppm F) Brush w/ full ribbon, 2x day / 2mins Receives: Drug: 0.412% stannous fluoride toothpaste and flat trimmed toothbrush; Drug: 0.76% Na MFP and flat trimmed toothbrush |
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 scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored
Measured: Baseline, 12 weeks (3 months), 24 weeks (6 months)
Turesky-modified Quigley-Hein Plaque Index
Using a red dye solution to disclose the plaque. A score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored
Measured: Baseline, 12 weeks (3 months), 24 weeks (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start9 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Cepeda-Bravo, D.D.S., M.S, Principal investigator, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917507
- Sponsor's protocol ID
- CRO-2026-7-PG-DR-DR
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride and a Standard Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.
- ClinicalTrials.gov ID
- NCT07917507
- Acronym / sponsor ID
- CRO-2026-7-PG-DR-DR
- Conditions
- Plaque, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Nov 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.
Clinical Research study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste | Experimental | Drug: 0.412% stannous fluoride toothpaste and flat trimmed toothbrush, Drug: 0.76% Na MFP and flat trimmed toothbrush0.412% SnF Brush w/ full ribbon, 2x day / 2mins |
| toothpaste | Active comparator | Drug: 0.412% stannous fluoride toothpaste and flat trimmed toothbrush, Drug: 0.76% Na MFP and flat trimmed toothbrush0.76% Na MFP, (1000 ppm F) Brush w/ full ribbon, 2x day / 2mins |
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 24 weeks (6 months) 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.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- Five or more carious lesions requiring immediate restorative treatment.
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 |
|---|---|---|
| 0.412% stannous fluoride toothpaste and flat trimmed toothbrushBrush with full ribbon, 2x day / 2mins | Drug | Toothpaste, toothpaste |
| 0.76% Na MFP and flat trimmed toothbrushBrush with full ribbon, 2x day / 2mins | Drug | Toothpaste, toothpaste |
Primary outcome
Loe-Silness Gingival Index
Time frame: Baseline, 12 weeks (3 months), 24 weeks (6 months)
score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored
Turesky-modified Quigley-Hein Plaque Index
Time frame: Baseline, 12 weeks (3 months), 24 weeks (6 months)
Using a red dye solution to disclose the plaque. A score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
Antonio Cepeda-Bravo, D.D.S., M.S principal investigator
Universidad Autonoma de San Luis Potosí
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 0.412% stannous fluoride toothpaste and flat trimmed toothbrush and 0.76% Na MFP and flat trimmed toothbrush in people with Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Dominican Republic.
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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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 Dominican Republic. 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?
This study is still under way. Results are not available in the source record yet.
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, 12 weeks (3 months), 24 weeks (6 months)). 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 4 Nov 2026.