PlaquePhase 3NCT07842991
Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
A Phase 3 study testing 0.45% SnF HW with NaF (1450 F), 67% Bicarbonate with NaF (1400 F) and Colgate Cavity Protection Toothpaste in people with Plaque and Dental Plaque, run by Colgate Palmolive at 1 site in Italy.
Trial summary
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental Plaque, Gingivitis
- What is being tested?
- 0.45% SnF HW with NaF (1450 F), 67% Bicarbonate with NaF (1400 F) and Colgate Cavity Protection Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jul 2026to Jan 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
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the study.
- Good general health.
- Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
- Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
- Signed Informed Consent Form
Who cannot join
- Orthodontic bands.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- 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 antibiotics any time during the one month 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.
- Received a dental prophylaxis in the two weeks prior to your initial examination.
- History of allergies to oral care/personal care consumer products or their ingredients.
- Having taken any prescription medicines that might interfere with the study outcome.
- If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
- Self-reported pregnant or breast feeding an infant.
- History of drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Odontoiatrica Montesani
Roma, Rome, 00187
Luigi Montesani, MD, DDS, +39-338-6187383, luigi@montesani.it
Luigi Montesani, MD, DDS
About this study
Official title: Clinical Evaluation of a Stannous Fluoride Toothpaste Versus a 67% Bicarbonate Toothpaste and Colgate Cavity Protection Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems: a Six-month Clinical Study in Italy
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months and six months of product use. All subjects will be followed for adverse events throughout the study.
- Conditions
- Plaque, Dental Plaque, Gingivitis
- Being tested
- 0.45% SnF HW with NaF (1450 F), 67% Bicarbonate with NaF (1400 F), Colgate Cavity Protection Toothpaste
- Medical subject headings
- Plaque, Amyloid, Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.45% SnF HW with NaF (1450 F)Drug
toothpaste
67% Bicarbonate with NaF (1400 F)Drug
toothpaste
Colgate Cavity Protection ToothpasteDrug
Toothpaste with MFP/NaF (1450 F)
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time Receives: Drug: 0.45% SnF HW with NaF (1450 F) |
| Positive Control | Active comparator | Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time Receives: Drug: 67% Bicarbonate with NaF (1400 F) |
| Negative Control | Active comparator | Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lobene Modified Gingivitis Assessment
Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces 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 scoreable surface and dividing that number by the total number of surfaces scored
Measured: Baseline, 3 month, 6 month
Saxton Gingival Bleeding Assessment
Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing
Measured: Baseline, 3 month, 6 month
Modified Quigley-Hein Plaque Index
First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces 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, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Montensani, DDS, Principal investigator, Clinica Odontoiatrica Montesani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842991
- Sponsor's protocol ID
- CRO-2026-07-PGN-GAD-ITA-YPZ
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Stannous Fluoride Toothpaste Versus a 67% Bicarbonate Toothpaste and Colgate Cavity Protection Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems: a Six-month Clinical Study in Italy
- ClinicalTrials.gov ID
- NCT07842991
- Acronym / sponsor ID
- CRO-2026-07-PGN-GAD-ITA-YPZ
- Conditions
- Plaque, Dental Plaque, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Sep 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.
Qualified subjects will be enrolled and randomized to either one of the three study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months and six months of product use. All subjects will be followed for adverse events throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: 0.45% SnF HW with NaF (1450 F)Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
| Positive Control | Active comparator | Drug: 67% Bicarbonate with NaF (1400 F)Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
| Negative Control | Active comparator | Drug: Colgate Cavity Protection ToothpasteApproximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the study.
- Good general health.
- Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
- Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
Key exclusion criteria (13 listed)
- Orthodontic bands.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- 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
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 |
|---|---|---|
| 0.45% SnF HW with NaF (1450 F)toothpaste | Drug | Test 1 toothpaste |
| 67% Bicarbonate with NaF (1400 F)toothpaste | Drug | Positive Control |
| Colgate Cavity Protection ToothpasteToothpaste with MFP/NaF (1450 F) | Drug | Negative Control |
Primary outcome
Lobene Modified Gingivitis Assessment
Time frame: Baseline, 3 month, 6 month
Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces 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 scoreable surface and dividing that number by the total number of surfaces scored
Saxton Gingival Bleeding Assessment
Time frame: Baseline, 3 month, 6 month
Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding, a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing
Modified Quigley-Hein Plaque Index
Time frame: Baseline, 3 month, 6 month
First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces 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 25 Sep 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.
Luigi Montensani, DDS principal investigator
Clinica Odontoiatrica Montesani
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 0.45% SnF HW with NaF (1450 F), 67% Bicarbonate with NaF (1400 F) and Colgate Cavity Protection Toothpaste in people with Plaque and Dental Plaque, run by Colgate Palmolive at 1 site in Italy.
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 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: looking for participants now, as of the sponsor's last update on 25 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 1 site in Italy. 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?
Contact Luigi Montensani, DDS (+39-338-6187383;, luigi@montensani.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lobene Modified Gingivitis Assessment (time frame: Baseline, 3 month, 6 month). The study lists 3 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 25 Sep 2026.