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

Extending Infection Control Dental Care to Nursing Home Residents Using Telehealth-Mediated Supervision: a Novel Solution to Nursing Home Acquired Pneumonia Morbidity and Mortality.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06890676
Acronym
NHOralHealth
Enrollment
150
Registered
2025-03-24
Start date
2024-03-01
Completion date
2026-08-28
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gingivitis, Oral Infections, Periapical Infections, Periodontal Disease, Periodontal Infections, Periodontitis, Pneumonia

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

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.

Interventions

OTHERComprehensive Oral Evaluation

A thorough check-up of teeth, gums, and surrounding tissues, including medical and dental history, to assess overall oral health and identify any infections.

OTHERIntraoral Complete Radiographic Series

A series of x-rays of the whole mouth intended to display the, teeth, roots, periapical areas, bone, and areas without teeth.

OTHER• Teledentistry-synchronous and asynchronous

The delivery or coordination of care for a patient using synchronous; real-time or aysnchronous communication between care providers or between care providers and a patient.

A therapeutic procedure designed to remove plaque and calculus (hardened plaque) causing gum infections that can lead to tooth loss and other medical complications.

PROCEDUREPeriodontal Maintenance Procedure

A periodic evaluation and therapeutic support procedure for patients with a history of gum infections.

PROCEDUREApplication of Caries Arresting Medicament

Topical application of decay arresting or inhibiting medicament.

OTHEROral Hygiene Assistance

Dental procedures aimed at educating patients on, and assisting patients with ,proper oral hygiene practices removing food debris, germ-laden plaque, and soft tartar using cloth wipes, toothbrush, floss, and using oral hygiene aids.

PROCEDUREReferral for Treatment of Acute Oral Infection

Diagnosis and treatment of oral infection outside the scope of a dental hygienist or Expanded Function Dental Assistant.

Sponsors

Missouri Department of Health and Senior Services
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The Primary investigator and Outcomes Assessor are blinded to the identities of the patients and facilities. The data will be pooled and considered in affregate.

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Periodontal HealthOne year from the delivery of the infection control interventional careI. To evaluate the periodontal health of nursing home residents who receive dental infection control treatment compared to their pre-treatment peroidontal assessment using periodontal probe and inflammation diagnostic criteria endorsed by the American Academy of Periodontists and the European Federation of Periodontists.

Secondary

MeasureTime frameDescription
Diabetic Glucose ControlOne year from the delivery of the infection control interventional careTo evaluate the level of glucose control of diabetic nursing home residents for 1 year after they received dental infection control treatment compared to glucose control of the same diabetic nursing home residents before receiving the treatment using serum HbA1c sampling
Oral Hygiene Assistance InstructionOne year from the delivery of the infection control interventional careTo evaluate the effectiveness of an oral hygiene assistance mentoring program for nursing home staff to improve the oral hygiene of the nursing residents using 'Hygienist Assessment of Resident Oral Hygiene' administered by visiting dental hygienists. This instrument rates oral hygiene on a scale of 1 (poor) to 5 (good). The individual scores will be reported as aggregate scores monthly using mean and standard deviation comparing resident oral hygiene.
Decay Stabilization TreatmentOne year from the delivery of the infection control interventional care#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 pre-treatment evaluation of untreated decay using physical inspection, dental radiographs, and infra-red decay detection. The individual treatment evaluations will be recorded in REDCap 6 and 12 month after treatment and summarized in aggregate in a table entitle: 'Outcomes of Decay Stabilization Treatment in Nursing Home Residents'. The outcome fields of the table are: # untreated/unstable Decayed teeth at Initial Examination; # untreated/unstable Decayed Teeth at 6 Month Evaluation; # untreated/unstable Decayed Teeth at Final Evaluation; % Change in Untreated/Unstable Decayed Teeth.
Pneumonia IncidenceOne year from the delivery of the infection control interventional careTo evaluate the incidence of pneumonia in the group of nursing home residents who received dental infection control treatment compared to the facility incidence of pneumonia preceding the start of the dental care project.
Patient's / Families' Perceived Value of Dental ProgramOne year from the delivery of the infection control interventional care.To evaluate the perceived value of this dental care program by residents and/or family members using Likert Scale evaluation entitled: 'Patient / Guardian assessment of Oral Healthcare Program in Residential Care Facilities'. The instrument uses a 1 t0 10 scale with 1 indicating a very low level of satisfaction and 10 indicating a very high level of satisfaction.
Nursing Home Staff Perceived Value of Dental ProgramOne year from the delivery of the infection control interventional careTo evaluate the perceived value of the dental care program by nursing home staff using Likert Scale evaluation entitled 'LTCF Staff Assessment of Oral Healthcare Program in Residential Care Facilities'. The instrument uses a 1 to 10 scale with 1 with 1 indicating a very low level of satisfaction and 10 indicating a very high level of satisfaction.
Dental Contractor Perceived Sustainability of Dental ProgramOne year from the delivery of the infection control interventional care.To evaluate the perceived sustainability of the dental care program by dental contractors using Likert Scale evaluation entitled: 'Contractor Assessment of Feasibility & Sustainability of Project'. This instrument uses a 1 to 10 scale with 1 indicating a low level of sustainability and significant barriers to sustainability and 10 being a high level of sustainability with few barriers to sustain the project.
Frailty AssessmentOne year from the delivery of the infection control interventional careTo evaluate the effectiveness of the Modified Frail Questionnaire as a screening instrument using a Likert Scale evaluation survey of attending dentists and by reporting adverse incidents encountered during the project. The Modified Frail Questionnaire evaluates five criteria: fatigue, resistance, ambulation, illnesses, and weight loss, yielding a 0 or 1 score for each category. Total category scores of 0 or 1 = low frailty; 2-3 = moderate frailty; 4-5 = high frailty. Attending dentists assess the effectiveness of the Frailty Questionnaire using a Likert Evaluation entitled: 'Supervising Dentist Assessment of the Modified Frail Questionnaire as a Risk Assessment Instrument' with 1 indicating a very low level of satisfaction and 10 indicating a very high level of satisfaction. Adverse incidents are reported using a protocol-prescribed form and will be reported in the discussion portion of the project report.

Countries

United States

Contacts

Primary ContactJulie Boeckman
julie.boeckman@health.mo.gov573-751-6249
Backup ContactGuy D Deyton, DDS
guydeyton@gmail.com816-809-5032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026