Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control (NHOralHealth)

Missouri Department of Health and Senior Services

Status

Enrolling

Conditions

Periodontitis

Diabetes

Periapical Infections

Oral Infections

Pneumonia

Periodontal Disease

Periodontal Infections

Gingivitis

Treatments

Other: Comprehensive Oral Evaluation

Other: Intraoral Complete Radiographic Series

Other: • Teledentistry-synchronous and asynchronous

Procedure: Periodontal Maintenance Procedure

Procedure: Referral for Treatment of Acute Oral Infection

Other: Oral Hygiene Assistance

Procedure: Periodontal Therapy

Procedure: Application of Caries Arresting Medicament

Study type

Interventional

Funder types

Other

Identifiers

NCT06890676

T1246090 (Other Grant/Funding Number)

24-0501

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

60 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Infection Control Arm

Experimental group

Description:

* 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.

Treatment: