An interventional study of 0.76% Sodium Monofluorophosphate Dentifrice and 0.454% Stannous Fluoride Dentifrice in Gingival Diseases, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Procter and Gamble · Not applicable, Interventional, and Treatment
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.
88 studies on the registry are indexed under Gingival Diseases; 23 are open to participants now.
This study's enrollment of 120 is above the median of 46 across 69 interventional studies indexed under Gingival Diseases.
Browse Gingival Diseases 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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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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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, 4.7 pH
Drug: 0.454% Stannous Fluoride Dentifrice
0.454% Stannous Fluoride, 5.8 pH
Drug: 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Number Bleeding Sites
Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time frame: 3 months, 1 month
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time frame: 3 months, 1 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Jun 2022, 2 months.
Of 43 interventional studies with no phase under Gingival Diseases, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tin Fluorides