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

Colgate-Palmolive

Status and phase: Invitation-only; Phase 4

Conditions: Diabetes Type 2; Periodontal Disease; Caries

Treatments: Behavioral: Diabetes Oral Health Program; Drug: Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash; Drug: Stannous Fluoride Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT07619729

CRO-2026-05-GoMo-Diabetes-GJ

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Type 2 Diabetes

Experimental group

Description:

This is a single-group study. All subjects will be enrolled in the experimental group.

Treatment:

Drug: Stannous Fluoride Dentifrice

Drug: Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash

Behavioral: Diabetes Oral Health Program