ElderlyPhase 4NCT07807397

Oral Hygiene Assistance Training Program

A Phase 4 study testing Stannous Fluoride Toothpaste (SnF), sodium fluoride 5000 ppm and cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash in people with Elderly and Periodontal Disease, run by Colgate Palmolive.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Elderly, Periodontal Disease, Gingivitis
What is being tested?: Stannous Fluoride Toothpaste (SnF), sodium fluoride 5000 ppm and cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: No sites listed yet
Study dates: 20 Sep 2026to Sep 2027
Phase: Phase 4

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

Fractured teeth and/or root tips present
Oral lesions
Grossly mobile teeth for Cohort B
Temporary crowns for Cohort B

About this study

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

Read the detailed description

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.

Conditions: Elderly, Periodontal Disease, Gingivitis, Caries,Dental
Being tested: Stannous Fluoride Toothpaste (SnF), sodium fluoride 5000 ppm, cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash, sodium fluoride Mouthwash, Chlorhexidine 0,12%
Keywords: Caries, Gingivitis, Nursing Home, Pneumonia, Periodontal Disease, Behavior Change, toothbrushing, mouthwash, toothpaste, Elderly
Medical subject headings: Periodontal Diseases, Gingivitis, Dental Caries, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stannous Fluoride Toothpaste (SnF)Drug
Cohort A will use a stannous fluoride toothpaste
sodium fluoride 5000 ppmDrug
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 mouthwashDrug
Cohort A will use an antiplaque/antigingivitis mouthwash
sodium fluoride MouthwashDrug
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 toothbrushDevice
Cohort B will use a u-shaped connected "smart" toothbrush
xylitol toothpasteOther
Cohort B will use a xylitol toothpaste

Study groups in NCT07807397
Study group	Role	What they receive
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. Receives: Drug: Stannous Fluoride Toothpaste (SnF); Drug: sodium fluoride 5000 ppm; Drug: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash; Drug: sodium fluoride Mouthwash; Drug: 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. Receives: Drug: sodium fluoride Mouthwash; Drug: Chlorhexidine 0,12%; Device: connected toothbrush; Other: xylitol toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of pneumonia
Incidence of pneumonia acquired during the study
Measured: 1 year

Secondary outcomes (6)

Diabetes status
Measured: every 3 months for 1 year
HbA1c value
Measured: Every 3 months for 1 year
Oral Health History
Significant history of oral health
Measured: Baseline
Oral Health Status
This includes plaque, calculus, stain, visible inflammation, and oral hygiene status
Measured: Monthly for one year
Level of adherence to oral hygiene regimen
This is a measure of how adherent the nursing home staff was in completing each instance of oral hygiene regimens for the subjects.
Measured: Monthly for 1 year
Satisfaction with program
This will be captured via surveys for the subjects, facility staff, and facility leadership at different times throughout the study.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 2026Sep 2027

First posted8 Sep 2026
Study start20 Sep 2026 (estimated)
Primary completionSep 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ElderlyStudies 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07807397
Sponsor's protocol ID: CRO-2026-06-Missouri-NH-GJ
Status last verified: Sep 2026
First submitted: 2 Sep 2026
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
A Clinician-Patient Dual Behavior Change Framework to Leverage Informed Digital Nudges to Reduce Hospital Readmissions and Improve Patient Outcomes: A Trial for Scalable Strategy to Reduce Readmissions (PREVENT-R)
Readmission, Readmission Rates
Recruiting
Frailty Training for Emergency Nurses: A Cluster RCT in Morocco
Frail Elderly, Frailty
RecruitingPhase 2
Chidamide, Lenalidomide, and Rituximab in Newly Diagnosed Elderly/unFit DE-DLBCL
Double Expressor DLBCL, ELDERLY PEOPLE
RecruitingPhase 1
MK-0947 PN-002: An Open-label Study to Evaluate Brain α-synuclein Deposition Using Positron Emission Tomography (PET) and [¹⁸F]MK-0947 in Participants With Parkinson's Disease (PD)
Parkinsons Disease (PD), Healthy Elderly Volunteers
Not yet recruiting
GOT VOICE GROUP SINGING
Elderly, Coronary Arterial Disease (CAD)

All Elderly trials