Oral Hygiene Assistance Training Program

Phase 4Not Yet RecruitingNCT07807397

Colgate Palmolive500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Elderly Periodontal Disease Gingivitis Caries,Dental

Interventions

Stannous Fluoride Toothpaste (SnF)DRUG

Cohort A will use a stannous fluoride toothpaste

sodium fluoride 5000 ppmDRUG

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 mouthwashDRUG

Cohort A will use an antiplaque/antigingivitis mouthwash

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of pneumonia

Incidence of pneumonia acquired during the study

Time frame: 1 year

Secondary Outcomes

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

Data from ClinicalTrials.gov

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