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Oral Hygiene in Assisted Living

Adapting an Evidence-Based Program That Improves Oral Hygiene and Health for Assisted Living Residents With Dementia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03892200
Enrollment
1405
Registered
2019-03-27
Start date
2019-10-01
Completion date
2025-03-13
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Long-Term Care

Keywords

Mouth Care

Brief 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.

Detailed description

It could be said that many dementia care and caregiver support interventions are too limited, focusing solely on psychosocial and behavioral concerns. These issues are important, but so too is the physical health of people with dementia -- especially because they are living longer and require more support with health care and activities of daily living. Just imagine the benefit of a physical health care intervention provided daily. Case in point: tooth brushing, flossing, and gum and denture care. Many people with dementia resist mouth care - almost 90% in nursing homes, in fact. As a result, only 16% have their teeth brushed regularly, putting them at risk for aspiration pneumonia when they inhale bacteria from their teeth, tongue, and gums. In 2013, the research team submitting this proposal developed one of the two existing dementia-focused mouth care programs for nursing homes -- Mouth Care Without a Battle (MCWB) -- which already has become a standard of nursing home care. MCWB changes caregivers' attitudes and behavior, improves oral health, and in a cluster randomized trial, MCWB provided by nursing assistants reduced pneumonia incidence by 32 percent. The next frontier is to extend MCWB to assisted living (AL), the primary long-term residential care provider for persons with dementia. There are 30,200 AL communities across the country; 90% of their 835,200 residents have cognitive impairment and 42% have moderate or severe dementia (and on average, five untreated oral health conditions), meaning MCWB has the potential to improve the health and quality of life of more than 350,000 AL residents with dementia annually. There is a unique and timely opportunity to transform MCWB so it is optimally suitable for AL, given the North Carolina Department of Health and Human Services (DHHS) Special Care Dentistry Program offer of partnership. Consequently, the investigators propose this nested cohort cluster randomized trial that will apply the NIH Stage Model and principles of the Science of Behavior Change (SOBC) to lay the groundwork for a pragmatic trial and real-world implementation of MCWB for AL residents with dementia and their caregivers. The aims of the proposed project are to refine MCWB (NIH Stage I/Aim 1), and examine research efficacy (NIH Stage II/Aim 2) and real-world efficacy (NIH Stage III/Aim 3), focusing on structural, social, and interpersonal mechanisms as the SOBC target. Aims 2 and 3 will use separate samples of AL communities (24 for Aim 2 and 28 for Aim 3) across the state's ten regions. Within each region, one-half of AL communities will be randomized to treatment (MCWB) and one-half to control, and the oral hygiene of up to 360 residents with dementia will be assessed through eight months. For Aim 3 there will be up to 233 residents assessed for four months. In Aim 2, a research dental hygienist will train AL staff on MCWB and provide ongoing support; in Aim 3, this responsibility will be transferred to community public health dental hygienists working with the DHHS. Family members (one per resident, up to 360 for Aim 2 and up to 233 for Aim 3) will also be interviewed about the resident. Assisted Living staff will also be interviewed at each baseline and follow-up visit (up to 360 for Aim 2 and up to 360 for Aim 3). Aim 1. Refine MCWB for implementation in assisted living (AL) communities. 1. Identify stakeholder perspectives. Interview (1) the administrator, health care supervisor, and a personal care aide (PCA) from 20 AL communities across North Carolina who have already been trained in MCWB by community-based public health dental hygienists from the DHHS Special Care Dentistry Program, and (2) the dental hygienists who provided that training, to learn attitudes regarding MCWB as developed for nursing homes, the extent to which care has changed, and recommended modifications to MCWB for AL. 2. Create a one-hour MCWB training video (web and digital versatile disc format) targeted to AL. Modifications include videorecording AL staff providing mouth care to residents with dementia, and interviews with residents and families; AL administrators, supervisors and PCAs; and dental hygienists. Aim 2. Evaluate research efficacy of the MCWB program, with training and support provided by an experienced research dental hygienist. 1. Evaluate MCWB in terms of (1) the reach of the intervention; (2) effects on mediators/targets of change at the organizational and individual level; (3) resident outcomes (oral hygiene, pneumonia, hospitalizations); (4) associations between change at the organizational and individual level and outcomes, and also associations with characteristics of the AL community and staff; and (5) attitudes, barriers, and facilitators. 2. Develop a coaching manual for community hygienists to provide training and support to AL staff, reflecting lessons-learned from analyses. Aim 3. Evaluate real-world efficacy of the MCWB program, transferring responsibility for training and support to community public health dental hygienists, thereby testing efficacy of a nationally generalizable model. 1. Assess dental hygienists' (up to N=24) self-efficacy to provide training and support at baseline and 4 months. 2. Evaluate MCWB as per Aim 2a, including examining associations with characteristics of the hygienists. 3. Compare implementation and effectiveness outcomes between research and real-world efficacy. 4. Refine the coaching manual for community dental hygienists to provide training and coaching, reflecting lessons-learned from analyses. By the conclusion of this project, MCWB will be ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care. Note that the CT.gov record includes only the assisted living residents enrolled in the clinical trial, not secondary participants (staff, hygienists).

Interventions

BEHAVIORALAim2 - Daily Mouth Care

Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim2 the intervention training is delivered by a research dental hygienist.

BEHAVIORALAim3 - Daily Mouth Care

Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities. For Aim3 the intervention training is delivered by state public health dental hygienists.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2Baseline VisitThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim24 Months Follow-up VisitThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim2Change from Baseline to 4 monthsThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim2Baseline VisitThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim24 Months Follow-up VisitThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim2Change from Baseline to 4 MonthsThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Denture Plaque Index Score (DPI) - Baseline-Aim2Baseline VisitThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.
Denture Plaque Index Score (DPI) - 4 Months-Aim24 Months Follow-up VisitThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.
Change in Denture Plaque Index Score (DPI) - 4 Months-Aim2Change from Baseline to 4 monthsThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.
Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim3Baseline VisitThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim34 Months Follow-up VisitThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Change in Plaque Index Score for Long-Term Care (PI-LTC) - 4 Months-Aim3Change from Baseline to 4 monthsThe Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Gingival Index Score for Long-Term Care (GI-LTC) - Baseline-Aim3Baseline VisitThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim34 Months Follow-up VisitThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Change in Gingival Index Score for Long-Term Care (GI-LTC) - 4 Months-Aim3Change from Baseline to 4 monthsThe Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.
Denture Plaque Index Score (DPI) - Baseline-Aim3Baseline VisitThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.
Denture Plaque Index Score (DPI) - 4 Months-Aim34 Months Follow-up visitThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.
Change in Denture Plaque Index Score (DPI) - 4 Months-Aim3Change from Baseline to 4 monthsThe Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.

Secondary

MeasureTime frameDescription
Number of Participants Diagnosed With Pneumonia-Aim2Cumulative from Baseline to Completion (up to 8 months)The total number of AL residents diagnosed with pneumonia.
Number of Participants With Hospitalizations-Aim2Cumulative from Baseline to Completion (up to 8 months)The total number AL residents with hospitalizations.
Number of Participants Diagnosed With Pneumonia-Aim3Cumulative from Baseline to Completion (up to 4 months)The total number of AL residents diagnosed with pneumonia.
Number of Participants With Hospitalizations-Aim3Cumulative from Baseline to Completion (up to 4 months)The total number of AL residents with hospitalizations.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSheryl Zimmerman, PhD

University of North Carolina, Chapel Hill

Participant flow

Recruitment details

For Aims 2 and 3, assisted living (AL) communities were recruited and randomized to treatment arms. Within communities, AL residents (primary participants) were recruited for observation at up to 3 timepoints (baseline, 4 months, 8 months). A total of 200+214=414 residents across 24+28=52 communities were enrolled. AL Staff (983=461+366+156) and public health dental hygienists (n=8) were also enrolled as secondary participants (not randomized and did not receive the intervention). Total = 1405.

Pre-assignment details

AL residents (n=414, primary) and dental hygienists (n=8, secondary) were interviewed at baseline and 4-months. AL staff (n=983=461+366+156, secondary) completed cross-sectional surveys at up to 3 timepoints but were not followed individually. To represent these different groups, they are shown below as "periods". The study protocol also describes instrument development in Aim 1 but it does not meet the definition for a clinical trial and is not included here.

Baseline characteristics

Characteristic
Age, Continuous
AL Residents at Baseline (Primary)
83.8 years
STANDARD_DEVIATION 9
Age, Continuous
AL Staff at 4-Months (Secondary)
40.2 years
STANDARD_DEVIATION 14.2
Age, Continuous
AL Staff at 8-Months (Secondary)
40.0 years
STANDARD_DEVIATION 13.5
Age, Continuous
AL Staff at Baseline (Secondary)
38.5 years
STANDARD_DEVIATION 13.8
Age, Continuous
Dental Hygienists at Baseline (Secondary)
44.3 years
STANDARD_DEVIATION 9.4
Ethnicity (NIH/OMB)
AL Residents (Primary)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
AL Residents (Primary)
Not Hispanic or Latino
93 Participants
Ethnicity (NIH/OMB)
AL Residents (Primary)
Unknown or Not Reported
11 Participants
Ethnicity (NIH/OMB)
AL Staff at 4-Months (Secondary)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
AL Staff at 4-Months (Secondary)
Not Hispanic or Latino
60 Participants
Ethnicity (NIH/OMB)
AL Staff at 4-Months (Secondary)
Unknown or Not Reported
19 Participants
Ethnicity (NIH/OMB)
AL Staff at 8-Months (Secondary)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
AL Staff at 8-Months (Secondary)
Not Hispanic or Latino
50 Participants
Ethnicity (NIH/OMB)
AL Staff at 8-Months (Secondary)
Unknown or Not Reported
26 Participants
Ethnicity (NIH/OMB)
AL Staff at Baseline (Secondary)
Hispanic or Latino
26 Participants
Ethnicity (NIH/OMB)
AL Staff at Baseline (Secondary)
Not Hispanic or Latino
82 Participants
Ethnicity (NIH/OMB)
AL Staff at Baseline (Secondary)
Unknown or Not Reported
29 Participants
Ethnicity (NIH/OMB)
Dental Hygienists (Secondary)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Dental Hygienists (Secondary)
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Dental Hygienists (Secondary)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
AL Residents (Primary)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
AL Residents (Primary)
Asian
0 Participants
Race (NIH/OMB)
AL Residents (Primary)
Black or African American
11 Participants
Race (NIH/OMB)
AL Residents (Primary)
More than one race
0 Participants
Race (NIH/OMB)
AL Residents (Primary)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
AL Residents (Primary)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
AL Residents (Primary)
White
99 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
Asian
2 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
Black or African American
36 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
More than one race
5 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
Unknown or Not Reported
9 Participants
Race (NIH/OMB)
AL Staff at 4-Months (Secondary)
White
33 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
Asian
1 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
Black or African American
72 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
More than one race
4 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
AL Staff at 8-Months (Secondary)
White
69 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
American Indian or Alaska Native
4 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
Asian
1 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
Black or African American
49 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
More than one race
14 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
Unknown or Not Reported
28 Participants
Race (NIH/OMB)
AL Staff at Baseline (Secondary)
White
54 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
Asian
0 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
Black or African American
1 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
More than one race
0 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Dental Hygienists (Secondary)
White
7 Participants
Region of Enrollment
United States
341 Participants
Sex/Gender, Customized
AL Residents (Primary)
Female
294 Participants
Sex/Gender, Customized
AL Residents (Primary)
Male
22 Participants
Sex/Gender, Customized
AL Residents (Primary)
Not Reported
2 Participants
Sex/Gender, Customized
AL Staff at 4-Months (Secondary)
Female
74 Participants
Sex/Gender, Customized
AL Staff at 4-Months (Secondary)
Male
2 Participants
Sex/Gender, Customized
AL Staff at 4-Months (Secondary)
Not Reported
13 Participants
Sex/Gender, Customized
AL Staff at 8-Months (Secondary)
Female
141 Participants
Sex/Gender, Customized
AL Staff at 8-Months (Secondary)
Male
2 Participants
Sex/Gender, Customized
AL Staff at 8-Months (Secondary)
Not Reported
3 Participants
Sex/Gender, Customized
AL Staff at Baseline (Secondary)
Female
95 Participants
Sex/Gender, Customized
AL Staff at Baseline (Secondary)
Male
6 Participants
Sex/Gender, Customized
AL Staff at Baseline (Secondary)
Not Reported
14 Participants
Sex/Gender, Customized
Period: Dental Hygienists (Secondary)
Female
8 Participants
Sex/Gender, Customized
Period: Dental Hygienists (Secondary)
Male
0 Participants
Sex/Gender, Customized
Period: Dental Hygienists (Secondary)
Not Reported
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
10 / 10119 / 992 / 1216 / 93
other
Total, other adverse events
24 / 10135 / 9921 / 1213 / 93
serious
Total, serious adverse events
20 / 10123 / 9914 / 1219 / 93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026