A Phase 4 interventional study of Stannous Fluoride Toothpaste (SnF) and sodium fluoride 5000 ppm in Elderly, Periodontal Disease and Gingivitis, sponsored by Colgate Palmolive. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Colgate Palmolive · Phase 4, Interventional, and Treatment
This is an oral health study with a nursing home staff training program and product intervention.
This study will be completed in partnership with the Missouri Department of Health and Senior Services, McCoy Samples Mattingly Dental Clinic, and Feno, inc. The study involves a nursing home staff training program, product intervention, and oral health outcomes.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 500 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
Compared within Gingivitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
Drug: Stannous Fluoride Toothpaste (SnF) · Drug: sodium fluoride 5000 ppm · Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash · Drug: sodium fluoride Mouthwash · Drug: Chlorhexidine 0,12%
Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.
Drug: sodium fluoride Mouthwash · Drug: Chlorhexidine 0,12% · Device: connected toothbrush · Other: xylitol toothpaste
Cohort A will use a stannous fluoride toothpaste
Cohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist.
Cohort A will use an antiplaque/antigingivitis mouthwash
Cohort A and Cohort B may use the sodium fluoride OTC mouthwash
Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash
Cohort B will use a u-shaped connected "smart" toothbrush
Cohort B will use a xylitol toothpaste
Incidence of pneumonia
Incidence of pneumonia acquired during the study
Time frame: 1 year
Diabetes status
Time frame: every 3 months for 1 year
HbA1c value
Time frame: Every 3 months for 1 year
Oral Health History
Significant history of oral health
Time frame: Baseline
Oral Health Status
This includes plaque, calculus, stain, visible inflammation, and oral hygiene status
Time frame: Monthly for one year
Level of adherence to oral hygiene regimen
This is a measure of how adherent the nursing home staff was in completing each instance of oral hygiene regimens for the subjects.
Time frame: Monthly for 1 year
Satisfaction with program
This will be captured via surveys for the subjects, facility staff, and facility leadership at different times throughout the study.
Time frame: 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tin Fluorides