PeriodontitisNHOralHealthNCT06890676
Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
A study testing Comprehensive Oral Evaluation, Intraoral Complete Radiographic Series and • Teledentistry-synchronous and asynchronous in people with Periodontitis and Gingivitis, run by Missouri Department of Health and Senior Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Periodontal Disease
- What is being tested?
- Comprehensive Oral Evaluation, Intraoral Complete Radiographic Series and • Teledentistry-synchronous and asynchronous
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 28 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Office of Dental Health, Department of Health and Senior Services
Jefferson City, Missouri, 65102
About this study
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.
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- 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.
- Conditions
- Periodontitis, Gingivitis, Periodontal Disease, Periodontal Infections, Oral Infections, Periapical Infections
- Being tested
- Comprehensive Oral Evaluation, Intraoral Complete Radiographic Series, • Teledentistry-synchronous and asynchronous, Periodontal Therapy, Periodontal Maintenance Procedure
- 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
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases, Pneumonia, Diabetes Mellitus, Dental Caries, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Oral EvaluationOther
Also called Oral Hygiene Assistance Arm, Data Collection Using Telehealth-Mediated Supervision
A thorough check-up of teeth, gums, and surrounding tissues, including medical and dental history, to assess overall oral health and identify any infections.
Intraoral Complete Radiographic SeriesOther
A series of x-rays of the whole mouth intended to display the, teeth, roots, periapical areas, bone, and areas without teeth.
• Teledentistry-synchronous and asynchronousOther
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.
Periodontal TherapyProcedure or surgery
Also called Periodontal Debridement, Scaling and Root Planing, Scaling in the Presence of Gingival Inflammation
A therapeutic procedure designed to remove plaque and calculus (hardened plaque) causing gum infections that can lead to tooth loss and other medical complications.
Periodontal Maintenance ProcedureProcedure or surgery
A periodic evaluation and therapeutic support procedure for patients with a history of gum infections.
Application of Caries Arresting MedicamentProcedure or surgery
Also called Fluoride Treatment, Silver Diamine Fluoride Treatment
Topical application of decay arresting or inhibiting medicament.
Oral Hygiene AssistanceOther
Also called Oral Hygiene Instruction, Toothbrushing, Denture Cleaning
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.
Referral for Treatment of Acute Oral InfectionProcedure or surgery
Also called Incision and Drainage, Antibiotic Therapy, Tooth Extraction
Diagnosis and treatment of oral infection outside the scope of a dental hygienist or Expanded Function Dental Assistant.
| Study group | Role | What they receive |
|---|---|---|
| Infection Control Arm | Experimental | * 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. Receives: Other: Comprehensive Oral Evaluation; Other: Intraoral Complete Radiographic Series; Other: • Teledentistry-synchronous and asynchronous; Procedure: Periodontal Therapy; Procedure: Periodontal Maintenance Procedure; Procedure: Application of Caries Arresting Medicament; Other: Oral Hygiene Assistance; Procedure: Referral for Treatment of Acute Oral Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Health
- 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.
Measured: One year from the delivery of the infection control interventional care
Secondary outcomes (8)
Pneumonia Incidence
To 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.
Measured: One year from the delivery of the infection control interventional care
Diabetic Glucose Control
To 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
Measured: One year from the delivery of the infection control interventional care
Oral Hygiene Assistance Instruction
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 '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.
Measured: One year from the delivery of the infection control interventional care
Decay Stabilization Treatment
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.
Measured: One year from the delivery of the infection control interventional care#
Frailty Assessment
To 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.
Measured: One year from the delivery of the infection control interventional care
Patient's / Families' Perceived Value of Dental Program
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.
Measured: One year from the delivery of the infection control interventional care.
Nursing Home Staff Perceived Value of Dental Program
To 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.
Measured: One year from the delivery of the infection control interventional care
Dental Contractor Perceived Sustainability of Dental Program
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.
Measured: One year from the delivery of the infection control interventional care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Mar 2024
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Missouri Department of Health and Senior Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Deyton, Missouri Department of Health and Senior Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890676
- Sponsor's protocol ID
- 24-0501
- Other IDs
- T1246090
- Acronym
- NHOralHealth
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed in aggregate to ensure the confidentiality of each study participant and the facilities involved in the study