NCT07807397

Brief Summary

This is an oral health study with a nursing home staff training program and product intervention.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
12mo left

Started Sep 2026

Shorter than P25 for phase_4

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

ElderlyPeriodontal DiseaseGingivitisCaries,Dental

Keywords

CariesGingivitisNursing HomePneumoniaPeriodontal DiseaseBehavior ChangetoothbrushingmouthwashtoothpasteElderly

Outcome Measures

Primary Outcomes (1)

  • Incidence of pneumonia

    Incidence of pneumonia acquired during the study

    1 year

Secondary Outcomes (6)

  • Diabetes status

    every 3 months for 1 year

  • HbA1c value

    Every 3 months for 1 year

  • Oral Health History

    Baseline

  • Oral Health Status

    Monthly for one year

  • Level of adherence to oral hygiene regimen

    Monthly for 1 year

  • +1 more secondary outcomes

Study Arms (2)

Cohort A

EXPERIMENTAL

Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.

Drug: Stannous Fluoride Toothpaste (SnF)Drug: sodium fluoride 5000 ppmDrug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashDrug: sodium fluoride MouthwashDrug: Chlorhexidine 0,12%

Cohort B

EXPERIMENTAL

Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.

Drug: sodium fluoride MouthwashDrug: Chlorhexidine 0,12%Device: connected toothbrushOther: xylitol toothpaste

Interventions

Stannous Fluoride Toothpaste (SnF)DRUG

Cohort A will use a stannous fluoride toothpaste

Cohort A
sodium fluoride 5000 ppmDRUG

Cohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist.

Cohort A
sodium fluoride MouthwashDRUG

Cohort A and Cohort B may use the sodium fluoride OTC mouthwash

Cohort ACohort B
Chlorhexidine 0,12%DRUG

Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash

Cohort ACohort B
connected toothbrushDEVICE

Cohort B will use a u-shaped connected "smart" toothbrush

Cohort B
xylitol toothpasteOTHER

Cohort B will use a xylitol toothpaste

Cohort B
cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashDRUG

Cohort A will use an antiplaque/antigingivitis mouthwash

Cohort A

Eligibility Criteria

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

You may qualify if:

  • Signed Informed Consent Form to receive on-site dental care and grant access to their medical and dental records, and Consent for information collection, consultation, and disease control oral healthcare treatment
  • Male and female subjects aged 60 years or older.
  • A resident of one of the nursing home sites.
  • ASA physical classification status of II, III, or IV (excluding high frailty scores)
  • Frailty assessment of low or moderate

You may not qualify if:

  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • History of allergies to oral care/personal care consumer products or their ingredients.
  • ASA category V patients
  • High frailty assessment
  • Resident deemed behaviorally difficult in interview or initial assessment
  • Endentulous
  • Fractured teeth and/or root tips present
  • Oral lesions
  • Grossly mobile teeth for Cohort B
  • Temporary crowns for Cohort B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesGingivitisDental CariesPneumonia

Interventions

CetylpyridiniumZincEthanol

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesTooth DemineralizationTooth DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be two cohorts in this study. Each cohort has a number of products from which the dentist and hygienist can choose for each patient.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09