GingivitisPhase 3NCT06770114
Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
A Phase 3 study testing Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash and PhosFlur Mouthwash in people with Gingivitis, run by Colgate Palmolive at 1 site in Italy.
Trial summary
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash and PhosFlur Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2021to 9 May 2022
- 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
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
- Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
- Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index.
- Signed Informed Consent Form.
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 ) or peri-implantitis.
- 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.
- An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
- History of alcohol or drug abuse.
- Self-reported pregnant or lactating subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC, and 0.1% Hyaluronic Acid and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
- Conditions
- Gingivitis
- Being tested
- Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash, PhosFlur Mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid MouthwashDrug
0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate
PhosFlur MouthwashDrug
0 .044 % sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| New Mouthwash containing CPC, Zinc and Hyaluronic acid | 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 spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months Receives: Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash |
| Fluoride Mouthwash | Active comparator | After brushing in the morning, 10 ml of mouthwash shall be used for each rinsing, 1 time daily (morning ) for 60 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months. Receives: Drug: PhosFlur Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mombelli Modified Gingival Index
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Measured: baseline
Mombelli Modified Gingival Index
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Measured: three month
Mombelli Modified Gingival Index
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Measured: six month
Mombelli Modified Plaque Index
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
Measured: baseline
Mombelli Modified Plaque Index
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
Measured: three month
Mombelli Modified Plaque Index
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start18 Oct 2021
- Primary completion9 May 2022
- Study completion9 May 2022
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
- Prevention
- 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
- NCT06770114
- Sponsor's protocol ID
- CRO-2021-12-PIM-IMW-ITA-YPZ
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 1 Dec 2025
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC, and 0.1% Hyaluronic Acid and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
- ClinicalTrials.gov ID
- NCT06770114
- Acronym / sponsor ID
- CRO-2021-12-PIM-IMW-ITA-YPZ
- Conditions
- Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 13 Jan 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.
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Mouthwash containing CPC, Zinc and Hyaluronic acid | Experimental | Drug: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid 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 spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months |
| Fluoride Mouthwash | Active comparator | Drug: PhosFlur MouthwashAfter brushing in the morning, 10 ml of mouthwash shall be used for each rinsing, 1 time daily (morning ) for 60 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
- Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
- Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index.
Key exclusion criteria (12 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 ) or peri-implantitis.
- 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, Zinc Lactate and Hyaluronic Acid Mouthwash0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate | Drug | New Mouthwash containing CPC, Zinc and Hyaluronic acid |
| PhosFlur Mouthwash0 .044 % sodium fluoride | Drug | Fluoride Mouthwash |
Primary outcome
Mombelli Modified Gingival Index
Time frame: baseline
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Mombelli Modified Gingival Index
Time frame: three month
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Mombelli Modified Gingival Index
Time frame: six month
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Mombelli Modified Plaque Index
Time frame: baseline
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
Mombelli Modified Plaque Index
Time frame: three month
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
Mombelli Modified Plaque Index
Time frame: six month
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
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 1 Dec 2025.
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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, Zinc Lactate and Hyaluronic Acid Mouthwash and PhosFlur Mouthwash in people with Gingivitis, 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 12 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 1 Dec 2025. 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?
Mombelli Modified Gingival Index (time frame: baseline). The study lists 6 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 1 Dec 2025.