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

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

Status
Enrolling by invitation
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07619729
Enrollment
10000
Registered
2026-06-02
Start date
2026-05-26
Completion date
2028-01-02
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Diabetes Type 2, Periodontal Disease

Keywords

type 2 diabetes, oral health, periodontal disease, caries

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.

Interventions

BEHAVIORALDiabetes Oral Health Program

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.

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.

DRUGCetylpyridinium Chloride (CPC) and Zinc Lactate 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.

Sponsors

Colgate Palmolive
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dental Claims12 monthsPercentage of preventive dental claims compared to treatment dental claims

Secondary

MeasureTime frameDescription
Product usage12 monthsNumber of subjects who opt-in to the product intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026