Clinical trial NCT06890676: Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
Official title: Extending Infection Control Dental Care to Nursing Home Residents Using Telehealth-Mediated Supervision: a Novel Solution to Nursing Home Acquired Pneumonia Morbidity and Mortality.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Gingivitis
Periodontal Disease
Periodontal Infections
Oral Infections
Periapical Infections
Pneumonia
Diabetes
Keywords: Nursing Home
Long-Term Care Facility
Dental Care
Dental Infections
Oral Infections
Periodontal Infections
Periodontal Diseases
Dental Caries
Pneumonia
Diabetes
Oral Hygiene
Caries Arrest
Frailty
Telehealth
Lead sponsor: Missouri Department of Health and Senior Services
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the periodontal health of nursing home residents who receive dental infection control treatment at their residential nursing care facility provided by dental hygienists and dental assistants compared to the pre-project health evaluations of the same patients using diagnostic criteria endorsed jointly by the American Academy of Periodontists and the European Federation of Periodontists.

SECONDARY OBJECTIVES II. To evaluate the incidence of pneumonia in the group of nursing home residents who received dental infection control treatment 1 year after treatment compared to the facility incidence of pneumonia for the same period preceding the start of the dental care project.

III. To evaluate the level of glucose control of diabetic nursing home residents for 1 year after they received dental infection control compared to glucose control of the same diabetic nursing home residents before receiving the treatment using serum HbA1c sampling.

IV. To evaluate the effectiveness of an oral hygiene assistance mentoring program for nursing home staff to improve the oral hygiene of the nursing residents using a simple resident oral hygiene evaluation instrument administered by visiting dental hygienists.

V. To evaluate the effectiveness of an oral hygiene assistance mentoring program for nursing home staff to increase their knowledge about oral hygiene and the relationship between oral infections and systemic disease using pre-course and post-course comprehension tests.

VI. To evaluate the effectiveness of decay stabilization treatment using topically applied fluoride and SMART fillings delivered to nursing home residents by hygienists and dental assistants compared to residents who do not receive such care using physical inspection and dental radiographs.

VII. To evaluate the effectiveness of using near-infrared imaging function of a continuous intraoral scan to evaluate decay stabilization treatment using topically applied fluoride and SMART fillings delivered to nursing home residents by hygienists and dental assistants compared to traditional dental radiographs and physical inspection using Likert surveys of attending dentists.

VIII. To evaluate the effectiveness of a novel frailty assessment instrument, the Modified Frail Questionnaire, as a screening instrument to discriminate nursing home residents who can be safely treated by hygienists and assistants in their residential facility using a Lickert Scale evaluation survey of attending dentists and by reporting adverse incidents encountered during the project.

IX. To evaluate the perceived value of this dental care program by residents and/or family members using Lickert Scale evaluations X. To evaluate the perceived value of the dental care program by nursing home staff using Likert Scale evaluations.

XI. To evaluate the perceived sustainability of the dental care program by dental contractors using Likert Scale evaluations.

Outline: Dental contractors were recruited by published RFA and attended an in-person workshop outlining study requirements, nursing home facility recruitment, participant informed consent process, and data submission requirements. Contractors met with nursing home facilities, educated them about the project, and enlisted staff assistance to recruit study participants from the census of residents of participating nursing homes. Residents were interviewed, educated, screened for inclusion and exclusion, and serially admitted to the study with signed consent for participation, dental infection control treatment, and access to their medical records.

Eligibility criteria: Inclusion Criteria:

* Adult \> 60 years of age residing in a nursing home or communal care setting;
* Review of Medical history results in an assigned American Society of Anesthesiologists Physical Status Evaluation of Class II or III;
* Frailty Assessment of Low or Moderate using the Modified FRAIL Questionnaire;
* Consent is required for study participation, disease control oral healthcare, and access to medical records.

Exclusion Criteria:

* Age \< 60;
* American Society of Anesthesiologists Physical Status Evaluation of Class IV or V;
* High frailty evaluation using the Modified FRAIL Questionnaire;
* Resident deemed behaviorally or physically difficult to treat by initial clinical assessment.

Primary outcomes:
measure: Periodontal Health
timeFrame: One year from the delivery of the infection control interventional care
Secondary outcomes:
measure: Pneumonia Incidence
timeFrame: One year from the delivery of the infection control interventional care
measure: Diabetic Glucose Control
timeFrame: One year from the delivery of the infection control interventional care
measure: Oral Hygiene Assistance Instruction
timeFrame: One year from the delivery of the infection control interventional care
measure: Decay Stabilization Treatment
timeFrame: One year from the delivery of the infection control interventional care#
measure: Frailty Assessment
timeFrame: One year from the delivery of the infection control interventional care
measure: Patient's / Families' Perceived Value of Dental Program
timeFrame: One year from the delivery of the infection control interventional care.
measure: Nursing Home Staff Perceived Value of Dental Program
timeFrame: One year from the delivery of the infection control interventional care
measure: Dental Contractor Perceived Sustainability of Dental Program
timeFrame: One year from the delivery of the infection control interventional care.
Other outcomes:
Locations:
city: Jefferson City
country: United States
facility: Office of Dental Health, Department of Health and Senior Services
state: Missouri
Study officials:
References: