CompletedNot Applicable

Oral Hygiene in Assisted Living

United States1,405 participantsStarted 2019-10-01

Plain-language summary

This project will modify a program that reduces pneumonia among nursing home residents with dementia, so that it is appropriate for assisted living residents with dementia. The program provides daily mouth care to reduce bacteria in the mouth that lead to aspiration pneumonia. The project will develop methods that can be taught to assisted living providers by community dental hygienists, and that are ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

RESIDENTS Inclusion Criteria: * Are 18 years of age or older * Have teeth or have and use a denture * Have a diagnosis of dementia Exclusion Criteria: * Requires antibiotic prophylaxis prior to oral hygiene examination * Currently on hospice or tube-feeding * Expected to die or be discharged in the next six months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2

Timeframe: Baseline Visit

Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2

Timeframe: 4 Months Follow-up Visit

Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2

Timeframe: Change from Baseline to 4 months

Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2

Timeframe: Baseline Visit

Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2

Timeframe: 4 Months Follow-up Visit

Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2

Timeframe: Change from Baseline to 4 Months

Denture Plaque Index Score (DPI) - Baseline-Aim2

Timeframe: Baseline Visit

Trial details

NCT IDNCT03892200

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-13

Results submitted2025-12-19

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2

Timeframe: Baseline Visit

Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2

Timeframe: 4 Months Follow-up Visit

Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2

Timeframe: Change from Baseline to 4 months

Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2

Timeframe: Baseline Visit

Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2

Timeframe: 4 Months Follow-up Visit

Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2

Timeframe: Change from Baseline to 4 Months

Denture Plaque Index Score (DPI) - Baseline-Aim2

Timeframe: Baseline Visit