PlaquePhase 3NCT07458464
Study to Investigate Toothpaste on Antibacterial Effects in the Different Regions of the Mouth
A Phase 3 study testing stannous fluoride toothpaste and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste in people with Plaque and Gingivitis, run by Colgate Palmolive at 2 sites in Thailand.
Trial summary
The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva 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?
- stannous fluoride toothpaste and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesThailand
- Study dates
- 18 May 2026to 28 Jun 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
- Male and female subjects, ages 18-70, inclusive.
- Subject is available during study duration and has no allergies to oral hygiene formulations.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
- Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
Who cannot join
- Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- History of dental prophylaxis or treatments in the past month or during study duration.
- History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- Subjects scheduled for medical procedures for the duration of the study.
- Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
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- History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Oral soft tissue pathology.
- History of active or severe periodontal disease and loose teeth.
- Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
- Fixed or removable orthodontic appliance or removable partial dentures.
- Self-reported pregnancy or lactation.
- Subjects known to be an alcoholic, or a recovering alcoholic.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Mahidol University
Bangkok, Bangkok 10110
Mahidol University
Ratchathewi, Bangkok, 10400
About this study
Official title: A Clinical Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste.
The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva
- Conditions
- Plaque, Gingivitis
- Being tested
- stannous fluoride toothpaste, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste
- 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.
stannous fluoride toothpasteDrug
toothpaste
0.76% Sodium Monofluorophosphate (Na MFP) toothpasteDrug
toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test 1 Toothpaste | Experimental | Instructed to brush will full ribbon, 2x day/2 min with toothpaste Receives: Drug: stannous fluoride toothpaste |
| Test 2 toothpaste | Active comparator | Instructed to brush will full ribbon, 2x day/2 min with toothpaste Receives: Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loe-Silness
gingivitis index of 1.0 or more
Measured: baseline, 2 week and 4 week
Turesky Modification of Quigley-Hein
whole mouth scores of dental plaque of 1.5 or more
Measured: baseline, 2 week and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start18 May 2026
- Primary completion28 Jun 2026
- Study completion28 Jun 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.
- 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
- 95 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
- NCT07458464
- Sponsor's protocol ID
- CRO-2026-05-BAC-SNI-THA-YPZ
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste.
- ClinicalTrials.gov ID
- NCT07458464
- Acronym / sponsor ID
- CRO-2026-05-BAC-SNI-THA-YPZ
- Conditions
- Plaque, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 28 Jun 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 9 Mar 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 clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva
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: stannous fluoride toothpasteInstructed to brush will full ribbon, 2x day/2 min with toothpaste |
| Test 2 toothpaste | Active comparator | Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpasteInstructed to brush will full ribbon, 2x day/2 min with toothpaste |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects, ages 18-70, inclusive.
- Subject is available during study duration and has no allergies to oral hygiene formulations.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
- Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
Key exclusion criteria (14 listed)
- Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- History of dental prophylaxis or treatments in the past month or during study duration.
- History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- Subjects scheduled for medical procedures for the duration of the study.
- Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
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 |
|---|---|---|
| stannous fluoride toothpastetoothpaste | Drug | Test 1 Toothpaste |
| 0.76% Sodium Monofluorophosphate (Na MFP) toothpastetoothpaste | Drug | Test 2 toothpaste |
Primary outcome
Loe-Silness
Time frame: baseline, 2 week and 4 week
gingivitis index of 1.0 or more
Turesky Modification of Quigley-Hein
Time frame: baseline, 2 week and 4 week
whole mouth scores of dental plaque of 1.5 or more
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 24 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stannous fluoride toothpaste and 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste in people with Plaque and Gingivitis, run by Colgate Palmolive at 2 sites in Thailand.
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 5 inclusion and 14 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 (time frame: baseline, 2 week and 4 week). 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 24 Sep 2026.