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
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.
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 →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.
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Exclusion Criteria:
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.
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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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.76% sodium monofluorophosphate
Drug: 0.76% Sodium Monofluorophosphate Dentifrice
0.454% stannous fluoride
Drug: 0.454% Stannous Fluoride Dentifrice
0.454% stannous fluoride
Drug: 0.454% Stannous Fluoride Dentifrice
Brush two times a day for 1 minute with manual toothbrush
Brush two times a day for 1 minute with manual toothbrush
Brush two times a day for 2 minutes with electric toothbrush
Number Bleeding Sites
Total number of bleeding sites
Time frame: 4 months
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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Studies of the drug tested here: Tin Fluorides