Oral Hygiene Assistance Training Program

NCT07807397 — Phase 4, Not yet recruiting, 500 participants, Colgate Palmolive

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07807397
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	500 (Estimated)
Sponsor	Colgate Palmolive (Industry); collaborators: McCoy Samples Mattingly Dental Clinic, FENO.Co
Conditions	Elderly, Periodontal Disease, Gingivitis, Caries,Dental
Interventions	Stannous Fluoride Toothpaste (SnF), sodium fluoride 5000 ppm, cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash, sodium fluoride Mouthwash, Chlorhexidine 0,12%, connected toothbrush, xylitol toothpaste (Drug, device, other)
Dates	start 2026-09-20 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-09-08, last updated 2026-09-08

-Summary

This is an oral health study with a nursing home staff training program and product intervention.

Expand all sections · Collapse all

+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Cohort A	Experimental	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 manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
Cohort B	Experimental	Drug: sodium fluoride Mouthwash; Drug: Chlorhexidine 0,12%; Device: connected toothbrush; Other: xylitol toothpaste	Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.

Stannous Fluoride Toothpaste (SnF) (Drug): Cohort A will use a stannous fluoride toothpaste
sodium fluoride 5000 ppm (Drug): Cohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist.
cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash (Drug): Cohort A will use an antiplaque/antigingivitis mouthwash
sodium fluoride Mouthwash (Drug): Cohort A and Cohort B may use the sodium fluoride OTC mouthwash
Chlorhexidine 0,12% (Drug): Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash
connected toothbrush (Device): Cohort B will use a u-shaped connected "smart" toothbrush
xylitol toothpaste (Other): Cohort B will use a xylitol toothpaste

+Outcome measures

Primary outcomes

Incidence of pneumonia [1 year]: Incidence of pneumonia acquired during the study

Secondary outcomes

Diabetes status [every 3 months for 1 year]
HbA1c value [Every 3 months for 1 year]
Oral Health History [Baseline]: Significant history of oral health
Oral Health Status [Monthly for one year]: This includes plaque, calculus, stain, visible inflammation, and oral hygiene status
Level of adherence to oral hygiene regimen [Monthly for 1 year]: This is a measure of how adherent the nursing home staff was in completing each instance of oral hygiene regimens for the subjects.
Satisfaction with program [1 year]: This will be captured via surveys for the subjects, facility staff, and facility leadership at different times throughout the study.

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Signed Informed Consent Form to receive on-site dental care and grant access to their medical and dental records, and Consent for information collection, consultation, and disease control oral healthcare treatment
* Male and female subjects aged 60 years or older.
* A resident of one of the nursing home sites.
* ASA physical classification status of II, III, or IV (excluding high frailty scores)
* Frailty assessment of low or moderate

Exclusion Criteria:

* Tumor(s) of the soft or hard tissues of the oral cavity.
* History of allergies to oral care/personal care consumer products or their ingredients.
* ASA category V patients
* High frailty assessment
* Resident deemed behaviorally difficult in interview or initial assessment
* Endentulous
* Fractured teeth and/or root tips present
* Oral lesions
* Grossly mobile teeth for Cohort B
* Temporary crowns for Cohort B