Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes

NCT07619729 — Phase 4, Enrolling by invitation, 10000 participants, Colgate Palmolive

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Clinical Study to Evaluate the Efficacy of an Oral Health Behavioral Intervention on Medical and Dental Claims in People With Diabetes

Registry	NCT07619729
Status	Enrolling by invitation
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	10000 (Estimated)
Sponsor	Colgate Palmolive (Industry)
Conditions	Diabetes Type 2, Periodontal Disease, Caries
Interventions	Diabetes Oral Health Program, Stannous Fluoride Dentifrice, Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash (Behavioral, drug)
Dates	start 2026-05-26, primary completion 2028-01-02 (estimated), completion 2028-01-02 (estimated), first posted 2026-06-02, last updated 2026-09-03
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Type 2 Diabetes	Experimental	Behavioral: Diabetes Oral Health Program; Drug: Stannous Fluoride Dentifrice; Drug: Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash	This is a single-group study. All subjects will be enrolled in the experimental group.

Diabetes Oral Health Program (Behavioral): 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 Dentifrice (Drug): 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 Mouthwash (Drug), also known as 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.

+Outcome measures

Primary outcomes

Dental Claims [12 months]: Percentage of preventive dental claims compared to treatment dental claims

Secondary outcomes

Product usage [12 months]: Number of subjects who opt-in to the product intervention

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Severe cognitive impairment.
* General anesthesia in the past 3 months.
* Type 1 diabetes.
* Self-reported pregnant.

+Locations (1)

Facility	City	Country	Status
Decentralized Site - Virtual/Remote (NY, USA)	Long Island City, New York	United States