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Active, not recruitingNCT06962956Updated Jun 3, 2025

Evaluating Gingivitis and Systemic Biomarkers

A Phase 1 interventional study of 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in Gingivitis, sponsored by Procter and Gamble. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Procter and Gamble · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.

02

Conditions studied

  • Gingivitis

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03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 135 is above the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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 ≥ 7), rheumatoid arthritis, liver disease, IBS, Crohn's Disease, Chronic Kidney Disease, or any type of 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
135 participants (estimated)

Study arms

  • Active comparator
    Negative Control

    0.76% sodium monofluorophosphate

    Drug: 0.76% Sodium Monofluorophosphate Dentifrice

  • Active comparator
    Test

    0.454% stannous fluoride

    Drug: 0.454% Stannous Fluoride Dentifrice

  • Active comparator
    Positive Control

    0.454% stannous fluoride

    Drug: 0.454% Stannous Fluoride Dentifrice

Interventions

06

What researchers measure

Primary outcomes

  1. Number Bleeding Sites

    Total number of bleeding sites

    Time frame: 4 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06962956
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
May 8, 2025
Start date
Apr 30, 2025
Primary completion
Oct 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Jun 3, 2025

Study contacts

Salus Research
principal investigator · Salus Research

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tin Fluorides

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