Aging, Long-Term Care
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score for Long-Term Care (PI-LTC) - Baseline-Aim2 | Baseline Visit | The 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-Aim2 | 4 Months Follow-up Visit | The 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-Aim2 | Change from Baseline to 4 months | The 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-Aim2 | Baseline Visit | The 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-Aim2 | 4 Months Follow-up Visit | The 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-Aim2 | Change from Baseline to 4 Months | The 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-Aim2 | Baseline Visit | The 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-Aim2 | 4 Months Follow-up Visit | The 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-Aim2 | Change from Baseline to 4 months | The 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-Aim3 | Baseline Visit | The 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-Aim3 | 4 Months Follow-up Visit | The 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-Aim3 | Change from Baseline to 4 months | The 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-Aim3 | Baseline Visit | The 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-Aim3 | 4 Months Follow-up Visit | The 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-Aim3 | Change from Baseline to 4 months | The 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-Aim3 | Baseline Visit | The 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-Aim3 | 4 Months Follow-up visit | The 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-Aim3 | Change from Baseline to 4 months | The 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Pneumonia-Aim2 | Cumulative from Baseline to Completion (up to 8 months) | The total number of AL residents diagnosed with pneumonia. |
| Number of Participants With Hospitalizations-Aim2 | Cumulative from Baseline to Completion (up to 8 months) | The total number AL residents with hospitalizations. |
| Number of Participants Diagnosed With Pneumonia-Aim3 | Cumulative from Baseline to Completion (up to 4 months) | The total number of AL residents diagnosed with pneumonia. |
| Number of Participants With Hospitalizations-Aim3 | Cumulative from Baseline to Completion (up to 4 months) | The total number of AL residents with hospitalizations. |
Countries
United States
Contacts
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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 101 | 19 / 99 | 2 / 121 | 6 / 93 |
| other Total, other adverse events | 24 / 101 | 35 / 99 | 21 / 121 | 3 / 93 |
| serious Total, serious adverse events | 20 / 101 | 23 / 99 | 14 / 121 | 9 / 93 |