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?

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 result in : * improved dental health * reduced risk of pneumonia * better glucose control for diabetic patients compared to the pre-project dental and general health evaluations of residents and the pre-project facility incidence of pneumonia. Dental infection control treatment includes treating gum infections, stopping or slowing decay with fluoride, and assisting residents with effective tooth brushing and denture cleaning daily. Previous studies indicate dental infections can be inhaled and cause pneumonia or make diabetes worse. A shortage of dentists has limited care for nursing home residents. This project will allow dental hygienists and specially trained dental assistants to treat nursing home residents using telehealth methods (computers, cameras, internet, and telephone) to talk and work with dentists in different locations.

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.

Is the dental care treatment for pneumonia prevention safe for humans?

The research suggests that dental care treatments, including tooth brushing and using a chlorhexidine oral rinse, are generally safe for nursing home residents and can help reduce pneumonia risk. ^{1 2 3 4 5}

How does the treatment 'Extending Basic Dental Care to Nursing Home Residents' differ from other treatments for pneumonia prevention?

This treatment is unique because it focuses on improving oral hygiene through regular tooth and gum brushing, using a chlorhexidine oral rinse, and ensuring proper feeding positions to prevent pneumonia, rather than relying on medications. It emphasizes the role of oral care in reducing pneumonia risk among nursing home residents. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Extending Basic Dental Care to Nursing Home Residents for pneumonia prevention?

Research shows that improving oral hygiene through education and integrated dental care can reduce the risk of pneumonia in older nursing home residents. This suggests that extending basic dental care to these residents may help prevent pneumonia by addressing oral health issues. ^{3 9 10 11 12}

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. United States pubmed.ncbi.nlm.nih.gov

Pilot testing of intervention protocols to prevent pneumonia in nursing home residents. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of integrated dental care on oral treatment needs in residents of nursing homes older than 70 years. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Dental service for nursing home residents in The Netherlands--the present situation]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Nursing education and improvement in oral care delivery in long-term care. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

An evidence-based oral hygiene education program for nursing staff. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Modification of the risk of mortality from pneumonia with oral hygiene care. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and acceptance of professional dental cleaning among nursing home residents. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Daily oral care and cough reflex sensitivity in elderly nursing home patients. [2006]

10. Japan pubmed.ncbi.nlm.nih.gov

[Oral care reduces pneumonia of elderly patients in nursing homes, irrespective of dentate or edentate status]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of professional and mechanical oral care for preventing pneumonia in nursing home residents. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Professional oral health care for preventing nursing home-acquired pneumonia: A cost-effectiveness and value of information analysis. [2018]