Oral Health Interventions for Older Adults

Overseen By Suchitra Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Dementia, Schizophrenia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

929 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve dental visit attendance among older adults with Medicaid who visit primary care clinics. It tests whether changes in electronic health records (EHR) and additional training for medical staff can encourage patients to see a dentist more regularly. Participants must be 55 or older, enrolled in the CareSource Medicaid plan, and attend non-urgent primary care visits in specific MetroHealth settings. The trial compares an intervention group receiving special training and EHR updates with a control group receiving standard oral health advice. The goal is to determine if the enhanced approach, known as the Oral Health Intervention, leads to better oral health habits and more frequent dental visits. As an unphased trial, this study allows participants to contribute to innovative strategies that could improve dental health care access 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 seems focused on oral health interventions and does not mention medication changes.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that maintaining oral health is crucial for staying healthy as you age, particularly for older adults. Good oral health can enhance overall health and reduce risks linked to poor dental hygiene. While specific safety details for these oral health methods aren't provided, the focus on improved dental visits and education suggests they are generally safe and well-accepted.

This trial is a Stage III cRCT, testing the effectiveness of these methods rather than introducing a new drug. This stage typically indicates that earlier tests have confirmed their safety. The trial emphasizes education and changes in dental care practices, which usually carry low risk. Therefore, participating in this trial is likely safe, with minimal chance of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Oral Health Interventions for older adults because they aim to enhance how dental care is integrated into overall healthcare. Unlike standard practices that typically involve basic oral health education, one arm of this trial introduces Electronic Health Record (EHR) changes and specialized training for medical staff. This approach uses CSM theory-based education, which focuses on understanding and improving patient self-management of oral health, and empowers clinicians with new skills. By integrating these innovative methods, the trial hopes to improve the way oral health is managed for older adults, potentially leading to better overall health outcomes.

What evidence suggests that this trial's interventions could be effective in increasing dental attendance among older adults?

This trial will compare different oral health interventions for older adults. Studies have shown that educating older individuals about oral and dental health can effectively enhance their oral health. Participants in Arm A of this trial will receive EHR Changes, EHR Training, and CSM theory-based Oral Health Training. Research indicates that this helps older adults understand the importance of regular dental visits and good oral hygiene. Meanwhile, Arm B will serve as a control arm with Standard ADA Oral Health Training. By asking about oral health risks, advising on dentist visits, and connecting patients to helpful resources, health providers can significantly increase dental visits. Evidence also suggests that better oral health education can lead to improved overall health, such as lower blood pressure and better control of blood sugar levels. This approach aims to facilitate dental care access and improve oral health for older adults. ^{6 7 8 9 10}

Who Is on the Research Team?

Suchitra Nelson, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for Medicaid-enrolled adults aged 55 or older who visit MetroHealth practices for non-urgent care and have low dental attendance. It aims to improve their oral health by testing new interventions.

Inclusion Criteria

Medical staff (MA, nurse) do not float between practices

Clinicians (Physician, NP) plan not to leave practice within a year

I am 55 years old or older.

Exclusion Criteria

Presence of any serious mental health disorders such as schizophrenia where the clinician indicates they should not participate

Presence of any serious medical health condition (such as dementia or other cognitive disorder not allowing them to participate) where the clinician indicates they should not participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Medical staff and clinicians receive training on EHR changes and oral health communication strategies

4-6 weeks

1-2 visits (in-person)

Intervention

Implementation of multi-level interventions including EHR changes and oral health communication during primary care visits

24 months

3 primary care visits (in-person)

Follow-up

Participants are monitored for dental attendance and changes in oral health quality of life and biometric measures

24 months

Follow-up assessments at each primary care visit

What Are the Treatments Tested in This Trial?

Interventions

• Oral Health Intervention

Trial Overview

The study tests a multi-level intervention against standard care. One group's EHR will prompt staff to discuss oral health (OH) risks, while clinicians receive special training on OH facts. The other group gets basic OH info without the EHR prompts.

How Is the Trial Designed?

Group I: Arm A: EHR Changes, EHR Training, and CSM theory-based Oral Health Training Experimental Treatment 2 Interventions

AAAC EHR Changes, Medical staff EHR Training, Clinician CSM theory based education and skills training

Group II: Arm B: Control Arm with Standard ADA Oral Health Training Active Control 1 Intervention

ADA-based education for clinicians only

Oral Health Intervention is already approved in United States for the following indications:

Approved in United States as Oral Health Intervention for:

• Improving dental utilization among Medicaid-enrolled older adults

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

Out of 16,060 patients treated at the School of Dentistry, only 0.26% (43 patients) reported adverse events, highlighting that such incidents are relatively rare but still significant.

A striking 97.7% of these adverse events were deemed preventable, with the majority occurring during clinical treatments by postgraduate students, indicating a need for improved training and safety protocols in dental education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia. Huertas, MF., Gonzalez, J., Camacho, S., et al.[2018]

The scoping review identified various interventions aimed at improving the oral health of older adults, highlighting the need for tailored approaches to address their specific dental care challenges.

The review emphasizes the importance of integrating oral health strategies into broader healthcare practices for older individuals to enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Settings-based Interventions at Primary, Secondary and Tertiary Prevention Levels May Significantly Improve the Oral Health of Older People. Hegde, S.[2021]

A scoping review of 81 studies on oral health interventions for people over 65 found that most interventions (64 out of 81) showed statistically significant benefits, indicating that various approaches can effectively improve oral health in older adults.

The majority of research focuses on primary prevention at the patient/carer level, highlighting a need for more studies targeting secondary prevention at the dentist level, using standardized outcome measures to enhance comparability and robustness of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve oral health of older people: A scoping review. Gomez-Rossi, J., Hertrampf, K., Abraham, J., et al.[2021]

Educational interventions aimed at improving oral health among older adults have been shown to be effective, as evidenced by a review of 23 studies, including 17 randomized controlled trials.

The review highlights the need for higher quality studies to further assess the effectiveness of these interventions, as many of the included studies were of moderate quality and varied in their approaches, with lectures being the most common method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health education interventions on oral health promotion among older people: a systematic review. Bashirian, S., Khoshravesh, S., Ayubi, E., et al.[2023]

As the elderly population retains more natural teeth and may use implants, maintaining oral health becomes increasingly important, necessitating more demanding oral self-care routines.

Effective strategies for preventing oral disease in the elderly include promoting overall health, educating through dental hygienists, using fluoride toothpaste, and providing regular professional support, especially for those who are less well or confused.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of oral hygiene programmes for elderly people--a review. de Baat, C., Kalk, W., Schuil, GR.[2019]

Approximately 3.4% of older adults visiting the dentist are prescribed drugs that could lead to serious drug interactions, highlighting a significant safety concern for dental practitioners.

Commonly prescribed drugs in dentistry that pose serious interaction risks include benzodiazepines, macrolide antibiotics, and nonsteroidal anti-inflammatory analgesics, emphasizing the need for careful management of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious drug-drug interactions among community-dwelling older adult dental patients. Skaar, DD., O'Connor, H.[2022]

In a review of 1000 patient records from 20 dental practices over 60 months, only 46 adverse events (AEs) were identified, indicating a low incidence of safety incidents in primary oral healthcare.

Of the AEs, 18 were deemed preventable, primarily related to treatment and diagnostics, suggesting that while primary oral care is generally safe, there is room for improvement in record keeping and incident prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in dental care: A challenging quality issue? An exploratory cohort study. Mettes, T., Bruers, J., van der Sanden, W., et al.[2013]

Between 2005 and 2014, there were 32,263 reported patient safety events in dentistry in England, with 43 classified as never events, primarily involving wrong site extractions, which often resulted in no harm or low harm.

Serious harm and death risks were notably higher in older patients (over 67 years) with medical complexities, particularly in acute trust wards and during oral surgery, highlighting the need for improved reporting and training to enhance patient safety in dental practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of never and serious events related to dentistry 2005-2014. Renton, T., Sabbah, W.[2018]

A new oral healthcare educational program involving weekly guidance from dental hygienists led to significant improvements in dental plaque levels among nursing home residents over a 3-month period, indicating enhanced oral health.

The intervention also increased nursing staff awareness of their limitations in oral health care and highlighted the importance of regular contact with dental services, suggesting that hands-on training may be more effective than traditional education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical and hands-on guidance from dental hygienists promotes good oral health in elderly people living in nursing homes, a pilot study. Seleskog, B., Lindqvist, L., Wårdh, I., et al.[2019]

A systematic review of 20 studies found that effective implementation strategies for improving oral health care in older adults in long-term care facilities often focus on enhancing knowledge, self-efficacy, and facilitating behavior change, primarily delivered by dental professionals and executed by nursing staff.

While strategies that increase knowledge and self-efficacy were successful, the overall quality and variability of the studies make it difficult to recommend specific strategies universally; care professionals should customize their approaches based on the specific needs and barriers of their target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral health care in older people in long term care facilities: a systematic review of implementation strategies. Weening-Verbree, L., Huisman-de Waal, G., van Dusseldorp, L., et al.[2022]

A 5-year community-based trial is being conducted to improve oral health among low-income older adults through a dual intervention approach that includes face-to-face counseling and resident-run oral health campaigns, involving 360 participants living in subsidized housing.

The study aims to assess the effectiveness of these interventions on oral health outcomes, such as plaque score and gingival index, and is designed to explore the sustainability of the interventions, potentially allowing for broader implementation in similar communities if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health). Schensul, J., Reisine, S., Grady, J., et al.[2020]

Over a six-year period, 287 adverse incidents were reported at a dental teaching hospital, representing only 0.039% of outpatient or day surgery appointments, indicating that while incidents do occur, they are relatively rare.

The majority of incidents (72%) happened during treatment or cleanup, with the most common issues arising from local anesthetic administration and dental handpiece burs, highlighting specific areas where safety protocols can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse incidents resulting in exposure to body fluids at a UK dental teaching hospital over a 6-year period. Hughes, A., Davies, L., Hale, R., et al.[2021]

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