NCT06890676

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Mar 2024Aug 2026

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

March 17, 2025

Last Update Submit

March 21, 2025

Conditions

Keywords

Nursing HomeLong-Term Care FacilityDental CareDental InfectionsOral InfectionsPeriodontal InfectionsPeriodontal DiseasesDental CariesPneumoniaDiabetesOral HygieneCaries ArrestFrailtyTelehealth

Outcome Measures

Primary Outcomes (1)

  • Periodontal Health

    I. 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.

    One year from the delivery of the infection control interventional care

Secondary Outcomes (8)

  • Pneumonia Incidence

    One year from the delivery of the infection control interventional care

  • Diabetic Glucose Control

    One year from the delivery of the infection control interventional care

  • Oral Hygiene Assistance Instruction

    One year from the delivery of the infection control interventional care

  • Decay Stabilization Treatment

    One year from the delivery of the infection control interventional care#

  • Frailty Assessment

    One year from the delivery of the infection control interventional care

  • +3 more secondary outcomes

Study Arms (1)

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.

Other: Comprehensive Oral EvaluationOther: Intraoral Complete Radiographic SeriesOther: • Teledentistry-synchronous and asynchronousProcedure: Periodontal TherapyProcedure: Periodontal Maintenance ProcedureProcedure: Application of Caries Arresting MedicamentOther: Oral Hygiene AssistanceProcedure: Referral for Treatment of Acute Oral Infection

Interventions

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

Also known as: Oral Hygiene Assistance Arm, Data Collection Using Telehealth-Mediated Supervision
Infection Control Arm

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

Infection Control Arm

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.

Infection Control Arm

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

Also known as: Periodontal Debridement, Scaling and Root Planing, Scaling in the Presence of Gingival Inflammation
Infection Control Arm

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

Infection Control Arm

Topical application of decay arresting or inhibiting medicament.

Also known as: Fluoride Treatment, Silver Diamine Fluoride Treatment
Infection Control Arm

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.

Also known as: Oral Hygiene Instruction, Toothbrushing, Denture Cleaning
Infection Control Arm

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

Also known as: Incision and Drainage, Antibiotic Therapy, Tooth Extraction
Infection Control Arm

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Office of Dental Health, Department of Health and Senior Services

Jefferson City, Missouri, 65102, United States

RECRUITING

Related Links

MeSH Terms

Conditions

PeriodontitisGingivitisPeriodontal DiseasesPneumoniaDiabetes MellitusDental CariesFrailty

Interventions

Periodontal DebridementTooth ExfoliationRoot PlaningFluoride TreatmentToothbrushingReferral and ConsultationDrainageAnti-Infective AgentsTooth Extraction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesTooth DemineralizationTooth DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingSubgingival CurettagePreventive DentistryFluoridationOral HygieneProfessional PracticeOrganization and AdministrationHealth Services AdministrationTherapeuticsSurgical Procedures, OperativeTherapeutic UsesPharmacologic ActionsChemical Actions and UsesOral Surgical Procedures

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Specialist

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

March 1, 2024

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Data will be analyzed in aggregate to ensure the confidentiality of each study participant and the facilities involved in the study

Locations