GingivitisPhase 3NCT07263698
Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash
A Phase 3 study testing cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash and sodium fluoride Mouthwash in people with Gingivitis and Plaque, Dental, run by Colgate Palmolive at 1 site in Italy.
Trial summary
Qualified subjects will be enrolled and randomized to either one of the two 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
- Gingivitis, Plaque, Dental
- What is being tested?
- cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash and sodium fluoride Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 27 Feb 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
- Subjects, ages 18-70, inclusive.
- Availability for the three-month duration of the clinical research study.
- Good general health.
- Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
- Signed Informed Consent Form (Appendix C)
Who cannot join
- Presence of 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.
- Antibiotic use any time during the one-month period prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Three-month Study in Italy
Qualified subjects will be enrolled and randomized to either one of the two 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 two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study
- Conditions
- Gingivitis, Plaque, Dental
- Being tested
- cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash, sodium fluoride Mouthwash
- Keywords
- Quigley-Hein Plaque Index, Modified Gingival
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride MouthwashDrug
0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride
sodium fluoride MouthwashDrug
100 ppm F as sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test 1 mouthwash | Experimental | After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time. No further rinsing with water shall be occurred after each mouthwash rising. Each qualified subject will follow this specific application for 3 months Receives: Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash |
| Test 2 mouthwash | Active comparator | After brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time Receives: Drug: sodium fluoride Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Gingival Index
A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.
Measured: baseline, 2 week, 6 week & 3 month
Saxton Bleeding Index
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, 2 week, 6 week & 3 month
Modified Quigley-Hein Plaque Index
Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome.
Measured: baseline, 2 week, 6 week & 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Montesani, DDS, Principal investigator, University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263698
- Sponsor's protocol ID
- CRO-2025-10-PGN-PRG-ITA-YPZ
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 26 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Three-month Study in Italy
- ClinicalTrials.gov ID
- NCT07263698
- Acronym / sponsor ID
- CRO-2025-10-PGN-PRG-ITA-YPZ
- Conditions
- Gingivitis, Plaque, Dental
- Keywords
- Quigley-Hein Plaque Index, Modified Gingival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 4 Dec 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.
Qualified subjects will be enrolled and randomized to either one of the two 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 two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study
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 mouthwash | Experimental | Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride MouthwashAfter brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time. No further rinsing with water shall be occurred after each mouthwash rising. Each qualified subject will follow this specific application for 3 months |
| Test 2 mouthwash | Active comparator | Drug: sodium fluoride MouthwashAfter brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds 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 three-month duration of the clinical research study.
- Good general health.
- Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
Key exclusion criteria (9 listed)
- Presence of 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.
- Antibiotic use any time during the one-month period prior to entry into 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 |
|---|---|---|
| cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride | Drug | Test 1 mouthwash |
| sodium fluoride Mouthwash100 ppm F as sodium fluoride | Drug | Test 2 mouthwash |
Primary outcome
Modified Gingival Index
Time frame: baseline, 2 week, 6 week & 3 month
A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.
Saxton Bleeding Index
Time frame: baseline, 2 week, 6 week & 3 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, 2 week, 6 week & 3 month
Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome.
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 26 May 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.
Luigi Montesani, DDS principal investigator
University of Rome
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 cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash and sodium fluoride Mouthwash in people with Gingivitis and Plaque, Dental, 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 9 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 26 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 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?
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?
Modified Gingival Index (time frame: baseline, 2 week, 6 week & 3 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 26 May 2026.