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NCT Number: NCT07807397

Oral Hygiene Assistance Training Program

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

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Key information

Conditions

Elderly Caries,Dental Dental Caries Gingival Diseases Gingivitis Infections Lung Diseases Mouth Diseases Periodontal Disease Periodontal Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This study will be completed in partnership with the Missouri Department of Health and Senior Services, McCoy Samples Mattingly Dental Clinic, and Feno, inc. The study involves a nursing home staff training program, product intervention, and oral health outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Stannous Fluoride Toothpaste (SnF)

Drug

Cohort A will use a stannous fluoride toothpaste

sodium fluoride 5000 ppm

Drug

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

cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash

Drug

Cohort A will use an antiplaque/antigingivitis mouthwash

sodium fluoride Mouthwash

Drug

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

Chlorhexidine 0,12%

Drug

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

connected toothbrush

Device

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

xylitol toothpaste

Other

Cohort B will use a xylitol toothpaste

Primary outcomes

  1. Incidence of pneumonia

    Time frame: 1 year

    Incidence of pneumonia acquired during the study

Secondary outcomes

  1. Diabetes status

    Time frame: every 3 months for 1 year

  2. HbA1c value

    Time frame: Every 3 months for 1 year

  3. Oral Health History

    Time frame: Baseline

    Significant history of oral health

  4. Oral Health Status

    Time frame: Monthly for one year

    This includes plaque, calculus, stain, visible inflammation, and oral hygiene status

  5. Level of adherence to oral hygiene regimen

    Time frame: Monthly for 1 year

    This is a measure of how adherent the nursing home staff was in completing each instance of oral hygiene regimens for the subjects.

  6. Satisfaction with program

    Time frame: 1 year

    This will be captured via surveys for the subjects, facility staff, and facility leadership at different times throughout the study.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Collaborators

  • FENO.Co
  • McCoy Samples Mattingly Dental Clinic

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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