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Enrolling by Invitation

NCT Number: NCT07619729

Evaluate the Efficacy of an Oral Health Behavioral Intervention 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.

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Key information

Conditions

Diabetes Type 2 Caries Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Disease Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Decentralized Site - Virtual/Remote (NY, USA)

Long Island City, New York, 11101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: CPC + Zn, CPC + Zinc, mouthwash

Primary outcomes

  1. Dental Claims

    Time frame: 12 months

    Percentage of preventive dental claims compared to treatment dental claims

Secondary outcomes

  1. Product usage

    Time frame: 12 months

    Number of subjects who opt-in to the product intervention

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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