Dental Care for Pneumonia Prevention

(NHOralHealth Trial)

Overseen By Guy D Deyton, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Missouri Department of Health and Senior Services

Disqualifiers: Age < 60, High frailty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether improving dental care for older adults in nursing homes can help prevent pneumonia and improve diabetes control. Dental hygienists visit nursing homes to treat gum infections, manage tooth decay, and assist with daily oral hygiene. The trial uses telehealth to connect with dentists remotely, ensuring residents receive necessary care. Participants should live in a nursing home, be over 60, and have manageable health conditions. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance dental care practices for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dental care to prevent pneumonia and improve health outcomes.

What prior data suggests that this dental infection control treatment is safe for nursing home residents?

Research has shown that better oral hygiene can lower the risk of pneumonia in older people living in nursing homes. Studies have found that regular dental care, such as cleaning teeth and treating gum problems, is safe. Previous findings suggest that ongoing dental care can help prevent pneumonia without causing harm. This indicates that the dental treatments under study are generally well-tolerated, especially since they use common methods like fluoride treatments and regular cleanings. Although specific data on side effects is lacking, the treatment relies on standard dental care practices, which are usually considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about extending basic dental care to nursing home residents because it takes a proactive approach to pneumonia prevention by addressing oral hygiene, which is often overlooked in current care routines. Unlike standard treatments that focus on managing pneumonia once it develops, this approach emphasizes infection control by using dental hygienists and EFDAs to prevent oral infections that can lead to respiratory issues. This method includes on-site dental care, telehealth consultations with supervising dentists, and training for long-term care staff, offering a comprehensive solution to maintain oral health and potentially reduce pneumonia risk.

What evidence suggests that extending basic dental care to nursing home residents could reduce the risk of pneumonia?

Research has shown that better dental care for older adults in nursing homes might lower their risk of pneumonia. This trial includes an Infection Control Arm where dental hygienists and EFDA teams provide extended dental care to residents. Studies have found that dental infections can be inhaled into the lungs, causing pneumonia, or can worsen diabetes. Regular dental care often correlates with better health and longer life. Dental treatments like tooth brushing and using a special mouth rinse called chlorhexidine are safe for nursing home residents and can help prevent infections. Although more high-quality research is needed, early results suggest that dental care can reduce health risks in these settings. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for older adult nursing home residents who may have dental health issues like gum disease or tooth abscesses. It aims to help those at risk of pneumonia or with diabetes needing better glucose control. Residents must not be currently receiving similar dental care.

Inclusion Criteria

Frailty Assessment of Low or Moderate using the Modified FRAIL Questionnaire

I agree to participate in the study and allow access to my medical records.

I am over 60 and live in a nursing home or similar place.

Exclusion Criteria

Resident deemed behaviorally or physically difficult to treat by initial clinical assessment

High frailty evaluation using the Modified FRAIL Questionnaire

I am under 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Dental hygienists and EFDA teams provide dental infection control treatment to nursing home residents using telehealth methods

12 months

Regular intervals (in-person and virtual)

Follow-up

Participants are monitored for periodontal health, pneumonia incidence, and glucose control for one year after treatment

12 months

Data collection and monitoring at regular intervals

Oral Hygiene Assistance Instruction

Evaluation of an oral hygiene assistance mentoring program for nursing home staff

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Extending Basic Dental Care to Nursing Home Residents

Trial Overview

The study tests if on-site dental treatments, including infection control, fluoride application, and daily oral hygiene assistance, can improve dental health and reduce pneumonia risks. It also uses telehealth for dentist consultations.

How Is the Trial Designed?

Group I: Infection Control Arm Experimental Treatment 8 Interventions

* Dental Hygienists and EFDA Teams travel to nursing homes and gather medical and dental data for residents participating in the study while collaborating with distant dentists using telehealth. * Clinical data is sent to the supervising dentist, who reviews medical history, assigns an ASA class and Frailty class, and prescribes an infection control treatment plan. * Emergent infections outside the scope of hygienists / EFDAs result in a transport order for care to an outside facility. * Hygienist/EFDA teams treat residents in their facility for gum infections, stabilize decay with fluoride and temporary fillings, and clean dentures. * The hygienist/EFDA team teaches LTCF staff oral hygiene assistance techniques to help residents with daily care and minimize reinfection. * The hygienist and EFDA team will continue to see LTCF residents at regular intervals to provide maintenance care, collect data, and monitor progress. * Treatment Outcome Data collected.

Who Is Running the Clinical Trial?

Missouri Department of Health and Senior Services

Lead Sponsor

Trials

1

Recruited

150+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06890676

Extending Dental Care to Nursing Home Residents ...

The goal of this study is to learn if dental infection control treatment delivered to older adult nursing home residents at their place of ...

2.

withpower.com

withpower.com/trial/phase-periapical-infections-2-2024-a1ff5

Dental Care for Pneumonia Prevention (NHOralHealth Trial)

The research suggests that dental care treatments, including tooth brushing and using a chlorhexidine oral rinse, are generally safe for nursing home residents ...

3.

smartpatients.com

smartpatients.com/trials/NCT06890676

Extending Dental Care to Nursing Home Residents ...

The goal of this study is to learn if dental infection control treatment delivered to older adult nursing home residents at their place of residence will ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6513285/

Oral care measures for preventing nursing home‐acquired ...

We found no high‐quality evidence to determine which oral care measures are most effective for reducing nursing home‐acquired pneumonia. Further trials are ...

5.

nature.com

nature.com/articles/s41598-024-84418-9

Contribution of dental treatment to reducing mortality in the ...

Patients who received more frequent dental care demonstrated improved survival outcomes. VAP did not significantly increase mortality risk in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7223037/

Enhanced oral hygiene interventions as a risk mitigation ...

Ongoing professional dental care is the most predictably effective preventive intervention for non-ventilated pneumonia (NVAP) for patients in ...