N/A N=414 Randomized Prevention

Oral Hygiene in Assisted Living

Aging · Long-Term Care

Bottom Line

View on ClinicalTrials.gov: NCT03892200 ↗

Enrolled (actual)

414

Serious AEs

15.9%

Results posted

Apr 2026

Primary outcome: Primary: Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2 — 1.6; 1.6 score on a scale — p=0.77

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aim2 - Daily Mouth Care (Behavioral); Aim3 - Daily Mouth Care (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Mar 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2	1.6; 1.6	0.77
PRIMARY Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2	1.6; 1.3	—
PRIMARY Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2	0.1; -0.3	<0.01 sig
PRIMARY Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2	1.8; 1.7	0.43
PRIMARY Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2	1.7; 1.3	—
PRIMARY Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2	0.0; -0.3	<.01 sig
PRIMARY Denture Plaque Index Score (DPI) - Baseline-Aim2	2.7; 2.3	0.25
PRIMARY Denture Plaque Index Score (DPI) - 4 Months-Aim2	2.4; 1.8	—
PRIMARY Change in Denture Plaque Index Score (DPI) - 4 Months-Aim2	-0.2; -0.7	0.15
PRIMARY Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim3	1.5; 1.7	0.21
PRIMARY Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3	1.5; 1.5	—
PRIMARY Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3	0.0; -0.2	0.33
PRIMARY Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim3	1.2; 1.5	0.01 sig
PRIMARY Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3	1.2; 1.2	—
PRIMARY Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3	-0.0; -0.3	0.07
PRIMARY Denture Plaque Index Score (DPI) - Baseline-Aim3	2.7; 2.4	0.31
PRIMARY Denture Plaque Index Score (DPI) - 4 Months-Aim3	2.3; 1.7	—
PRIMARY Change in Denture Plaque Index Score (DPI) - 4 Months-Aim3	-0.5; -0.8	0.51
SECONDARY Number of Participants Diagnosed With Pneumonia-Aim2	5; 4	—
SECONDARY Number of Participants With Hospitalizations-Aim2	12; 18	—
SECONDARY Number of Participants Diagnosed With Pneumonia-Aim3	3; 0	—
SECONDARY Number of Participants With Hospitalizations-Aim3	12; 9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03892200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.