Elderly, Periodontal Disease, Gingivitis, Caries,Dental
Conditions
Keywords
Caries, Gingivitis, Nursing Home, Pneumonia, Periodontal Disease, Behavior Change, toothbrushing, mouthwash, toothpaste, Elderly
Brief summary
This is an oral health study with a nursing home staff training program and product intervention.
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.
Interventions
Cohort A will use a stannous fluoride toothpaste
DRUGsodium fluoride 5000 ppm
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
DEVICEconnected toothbrush
Cohort B will use a u-shaped connected "smart" toothbrush
OTHERxylitol toothpaste
Cohort B will use a xylitol toothpaste
Sponsors
FENO.Co
Colgate Palmolive
McCoy Samples Mattingly Dental Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There will be two cohorts in this study. Each cohort has a number of products from which the dentist and hygienist can choose for each patient.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pneumonia | 1 year | Incidence of pneumonia acquired during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed