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

NCT07619729 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: CRO-2026-05-GoMo-Diabetes-GJ
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 2; Periodontal Disease; Caries

Keywords

type 2 diabetes; oral health; periodontal disease; caries

Outcome Measures

Primary Outcomes (1)

• Dental Claims

  Percentage of preventive dental claims compared to treatment dental claims

  12 months

Secondary Outcomes (1)

• Product usage

  12 months

Study Arms (1)

Type 2 Diabetes

EXPERIMENTAL

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

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

Interventions

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.

Type 2 Diabetes

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.

Type 2 Diabetes

Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash 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.

Also known as: CPC + Zn, CPC + Zinc, mouthwash

Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Decentralized Site - Virtual/Remote (NY, USA)

Long Island City, New York, 11101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases

Interventions

Cetylpyridinium; cytidylyl-(3'-5')-cytidine; Zinc; Mouthwashes

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

US (1)