GingivitisPhase 1NCT06962956
Evaluating Gingivitis and Systemic Biomarkers
A Phase 1 study testing 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 31 Oct 2025
- Phase
- Phase 1
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide informed consent and receive a signed copy of the informed consent form;
- Be between 25 - 65 years of age;
- Have at least 16 gradable teeth;
- Have a minimum of (approximately) 30% of bleeding sites and no more than two teeth with pockets deeper than 5mm or deemed acceptable by the Investigator/Designee (unhealthy test subjects only);
- Have less than or equal to 3 bleeding sites and with all pockets less than or equal to 3mm deep (healthy test subjects only);
- Agree to fast 12 hours prior to any visit with a blood collection;
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- Agree to not perform any oral hygiene for at least 12 hours prior to any visit with dental exams, saliva collection, and plaque collections;
- Agree to refrain from eating or drinking, using medicated lozenges, breaths mints, and chewing gum at least 4 hours prior to this study visit (exception allowed: small sips of water up until 45 minutes prior to their appointment) for any visit with plaque collections;
- Agree to refrain from use of any non-study oral hygiene products after the Product Distribution visit;
- Agree to continue their current oral hygiene products and habits until the Product Distribution visit;
- Agree to delay any elective dentistry, including dental prophylaxis outside of the study protocol, until the completion of the study;
- Agree to all study restrictions for the duration of the study (medicines/supplements/vaccines- see restricted list);
- Agree not to participate in any other oral care studies for the duration of this study;
- Agree to return for all scheduled visits and to follow all study procedures; and
- Be in good general health, as determined by the Investigator/Designee based on a review of their health history.
Who cannot join
- Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for gingivitis, periodontitis, or caries;
- Daily use of NSAID;
- Having any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, peri/oral piercings, a pacemaker or other implanted device, unless deemed acceptable by the Investigator/Designee;
- A condition requiring the need for antibiotic premedication prior to dental procedures;
- Use of anti-inflammatory or anti-coagulant medications within 2 weeks of the Baseline visit, unless deemed acceptable by the Investigator/Designee;
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- Having had oral/gum surgery within the previous 2 months;
- Smoking or vaping (regardless of content), use of smokeless tobacco, e-cigarettes, or nicotine patches);
- Currently using recreational drugs;
- Having been diagnosed with cardiovascular disease, diabetes (having an A1C ≥ 7), rheumatoid arthritis, liver disease, IBS, Crohn's Disease, Chronic Kidney Disease, or any type of autoimmune disease;
- Having any gastrointestinal issues (e.g. diarrhea, vomiting) in the past week;
- Use of statins or cholesterol lowering medication or supplements (e.g., Flax seeds, omega-3 fatty acids, Magnesium Oxide ≥250mg, Zyflamed, supplements containing berberine, golden thread, turmeric, CoQ10, or quercetin) for the duration of the study;
- Use of antibiotics or having a dental prophylaxis in the last 4 weeks prior the baseline visit, unless deemed acceptable by the Investigator/Designee;
- Receiving a flu shot or other vaccination in the last 4 weeks prior the baseline visit;
- Inability to undergo any study procedures;
- Currently undergoing treatment with GLP-1s antagonist;
- Nursing, self-reported pregnancy or the intention of becoming pregnant any time during the course of this study; or
- Having any condition or disease, as determined by the Investigator/Designee based on a review of the medical history which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers
This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.
- Conditions
- Gingivitis
- Being tested
- 0.76% Sodium Monofluorophosphate Dentifrice, 0.454% Stannous Fluoride Dentifrice
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.76% Sodium Monofluorophosphate DentifriceDrug
Brush two times a day for 1 minute with manual toothbrush
0.454% Stannous Fluoride DentifriceDrug
Brush two times a day for 1 minute with manual toothbrush
0.454% Stannous Fluoride DentifriceDrug
Brush two times a day for 2 minutes with electric toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | Active comparator | 0.76% sodium monofluorophosphate Receives: Drug: 0.76% Sodium Monofluorophosphate Dentifrice |
| Test | Active comparator | 0.454% stannous fluoride Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
| Positive Control | Active comparator | 0.454% stannous fluoride Receives: Drug: 0.454% Stannous Fluoride Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Bleeding Sites
Total number of bleeding sites
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start30 Apr 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salus Research, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962956
- Sponsor's protocol ID
- 2024058
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Relationship Between Gingivitis and Systemic Biomarkers
- ClinicalTrials.gov ID
- NCT06962956
- Acronym / sponsor ID
- 2024058
- Conditions
- Gingivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 8 May 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.
This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control | Active comparator | Drug: 0.76% Sodium Monofluorophosphate Dentifrice0.76% sodium monofluorophosphate |
| Test | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice0.454% stannous fluoride |
| Positive Control | Active comparator | Drug: 0.454% Stannous Fluoride Dentifrice0.454% stannous fluoride |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provide informed consent and receive a signed copy of the informed consent form;
- Be between 25 - 65 years of age;
- Have at least 16 gradable teeth;
- Have a minimum of (approximately) 30% of bleeding sites and no more than two teeth with pockets deeper than 5mm or deemed acceptable by the Investigator/Designee (unhealthy test subjects only);
- Have less than or equal to 3 bleeding sites and with all pockets less than or equal to 3mm deep (healthy test subjects only);
Key exclusion criteria (18 listed)
- Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for gingivitis, periodontitis, or caries;
- Daily use of NSAID;
- Having any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, peri/oral piercings, a pacemaker or other implanted device, unless deemed acceptable by the Investigator/Designee;
- A condition requiring the need for antibiotic premedication prior to dental procedures;
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 |
|---|---|---|
| 0.76% Sodium Monofluorophosphate DentifriceBrush two times a day for 1 minute with manual toothbrush | Drug | Negative Control |
| 0.454% Stannous Fluoride DentifriceBrush two times a day for 1 minute with manual toothbrush | Drug | Test |
| 0.454% Stannous Fluoride DentifriceBrush two times a day for 2 minutes with electric toothbrush | Drug | Positive Control |
Primary outcome
Number Bleeding Sites
Time frame: 4 months
Total number of bleeding sites
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 3 Jun 2025.
Related trials for Gingivitis
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Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
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Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
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Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
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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.
Salus Research principal investigator
Salus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in people with Gingivitis, run by Procter and Gamble at 1 site in United States.
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 15 inclusion and 18 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 3 Jun 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number Bleeding Sites (time frame: 4 months). 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 3 Jun 2025.