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.
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
- Are there results?
- Not yet: the study is under way
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McCoy Samples Mattingly Dental Clinic, FENO.Co
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hygiene Assistance Training Program
- ClinicalTrials.gov ID
- NCT07807397
- Acronym / sponsor ID
- CRO-2026-06-Missouri-NH-GJ
- Conditions
- Elderly, Periodontal Disease, Gingivitis, Caries,Dental
- Keywords
- Caries, Gingivitis, Nursing Home, Pneumonia, Periodontal Disease, Behavior Change, toothbrushing, mouthwash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- McCoy Samples Mattingly Dental Clinic, FENO.Co
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an oral health study with a nursing home staff training program and product intervention.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | 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%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. |
| Cohort B | Experimental | Drug: sodium fluoride Mouthwash, Drug: Chlorhexidine 0,12%, Device: connected toothbrush, Other: xylitol toothpasteSubjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stannous Fluoride Toothpaste (SnF)Cohort A will use a stannous fluoride toothpaste | Drug | Cohort A |
| sodium fluoride 5000 ppmCohort A will have the option of using a sodium fluoride 5000 ppm toothpaste if prescribed by the dentist. | Drug | Cohort A |
| cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwashCohort A will use an antiplaque/antigingivitis mouthwash | Drug | Cohort A |
| sodium fluoride MouthwashCohort A and Cohort B may use the sodium fluoride OTC mouthwash | Drug | Cohort A, Cohort B |
| Chlorhexidine 0,12%Cohort A and Cohort B may use a 0.12% chlorhexidine alcohol free mouthwash | Drug | Cohort A, Cohort B |
| connected toothbrushCohort B will use a u-shaped connected "smart" toothbrush | Device | Cohort B |
| xylitol toothpasteCohort B will use a xylitol toothpaste | Other | Cohort B |
Primary outcome
Incidence of pneumonia
Time frame: 1 year
Incidence of pneumonia acquired during the study
6 secondary outcomes
Diabetes status
Time frame: every 3 months for 1 year
HbA1c value
Time frame: Every 3 months for 1 year
Oral Health History
Time frame: Baseline
Oral Health Status
Time frame: Monthly for one year
Level of adherence to oral hygiene regimen
Time frame: Monthly for 1 year
Satisfaction with program
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.