Diabetes Type 2Phase 4NCT07619729
Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes
A Phase 4 study testing Diabetes Oral Health Program, Stannous Fluoride Dentifrice and Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash in people with Diabetes Type 2 and Periodontal Disease, run by Colgate Palmolive at 1 site in United States.
Trial summary
The purpose of this clinical study is to evaluate the effect of a behavioral intervention on the number of preventive and treatment dental claims in a population of people with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, Periodontal Disease, Caries
- What is being tested?
- Diabetes Oral Health Program, Stannous Fluoride Dentifrice and Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 2 Jan 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consented to participation in the Fidelis Care Diabetes Care program.
- Aged 18 years and older
- English speaking.
- Willing and able to receive text messages, and participate in online activities for the duration of the program.
- Diagnosis of Type 2 Diabetes.
Who cannot join
- Severe cognitive impairment.
- General anesthesia in the past 3 months.
- Type 1 diabetes.
- Self-reported pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Decentralized Site - Virtual/Remote (NY, USA)
Long Island City, New York, 11101
About this study
Official title: Clinical Study to Evaluate the Efficacy of an Oral Health Behavioral Intervention on Medical and Dental Claims in People With Diabetes
The purpose of this clinical study is to evaluate the effect of a behavioral intervention on the number of preventive and treatment dental claims in a population of people with Type 2 Diabetes.
- Conditions
- Diabetes Type 2, Periodontal Disease, Caries
- Being tested
- Diabetes Oral Health Program, Stannous Fluoride Dentifrice, Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash
- Keywords
- type 2 diabetes, oral health, periodontal disease, caries
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Oral Health ProgramBehavioural
All subjects will receive a behavioral intervention through text messages with links to educational pages about oral health or diabetes. Subjects will have the option of selecting in to the product intervention.
Stannous Fluoride DentifriceDrug
This is an opt-in product intervention, and it is expected that not all subjects will opt-in. Subjects will need to re-order the product every 3 months. All subjects who order product will receive a toothbrush, toothpaste, and mouthwash.
Cetylpyridinium Chloride (CPC) and Zinc Lactate MouthwashDrug
Also called CPC + Zn, CPC + Zinc, mouthwash
This is an opt-in product intervention, and it is expected that not all subjects will opt-in. Subjects will need to re-order the product every 3 months. All subjects who order product will receive a toothbrush, toothpaste, and mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Experimental | This is a single-group study. All subjects will be enrolled in the experimental group. Receives: Behavioral: Diabetes Oral Health Program; Drug: Stannous Fluoride Dentifrice; Drug: Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Claims
Percentage of preventive dental claims compared to treatment dental claims
Measured: 12 months
Secondary outcomes (1)
Product usage
Number of subjects who opt-in to the product intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start26 May 2026
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619729
- Sponsor's protocol ID
- CRO-2026-05-GoMo-Diabetes-GJ
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of an Oral Health Behavioral Intervention on Medical and Dental Claims in People With Diabetes
- ClinicalTrials.gov ID
- NCT07619729
- Acronym / sponsor ID
- CRO-2026-05-GoMo-Diabetes-GJ
- Conditions
- Diabetes Type 2, Periodontal Disease, Caries
- Keywords
- type 2 diabetes, oral health, periodontal disease, caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 2 Jan 2028 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 2 Jun 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.
The purpose of this clinical study is to evaluate the effect of a behavioral intervention on the number of preventive and treatment dental claims in a population of people with Type 2 Diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | Experimental | Behavioral: Diabetes Oral Health Program, Drug: Stannous Fluoride Dentifrice, Drug: Cetylpyridinium Chloride (CPC) and Zinc Lactate MouthwashThis is a single-group study. All subjects will be enrolled in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consented to participation in the Fidelis Care Diabetes Care program.
- Aged 18 years and older
- English speaking.
- Willing and able to receive text messages, and participate in online activities for the duration of the program.
- Diagnosis of Type 2 Diabetes.
Key exclusion criteria (4 listed)
- Severe cognitive impairment.
- General anesthesia in the past 3 months.
- Type 1 diabetes.
- Self-reported pregnant.
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 |
|---|---|---|
| Diabetes Oral Health ProgramAll subjects will receive a behavioral intervention through text messages with links to educational pages about oral health or diabetes. Subjects will have the option of selecting in to the product intervention. | Behavioural | Type 2 Diabetes |
| Stannous Fluoride DentifriceThis is an opt-in product intervention, and it is expected that not all subjects will opt-in. Subjects will need to re-order the product every 3 months. All subjects who order product will receive a toothbrush, toothpaste, and mouthwash. | Drug | Type 2 Diabetes |
| Cetylpyridinium Chloride (CPC) and Zinc Lactate MouthwashAlso: CPC + Zn, CPC + Zinc, mouthwashThis is an opt-in product intervention, and it is expected that not all subjects will opt-in. Subjects will need to re-order the product every 3 months. All subjects who order product will receive a toothbrush, toothpaste, and mouthwash. | Drug | Type 2 Diabetes |
Primary outcome
Dental Claims
Time frame: 12 months
Percentage of preventive dental claims compared to treatment dental claims
1 secondary outcome
Product usage
Time frame: 12 months
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diabetes Oral Health Program, Stannous Fluoride Dentifrice and Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash in people with Diabetes Type 2 and Periodontal Disease, run by Colgate Palmolive at 1 site in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dental Claims (time frame: 12 months). 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 3 Sep 2026.