Enrolling by invitation NCT07619729
Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diabetes Oral Health Program, Stannous Fluoride Dentifrice, Cetylpyridinium Chloride (CPC) and Zinc Lactate Mouthwash.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2, Periodontal Disease, Caries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study to Evaluate the Efficacy of an Oral Health Behavioral Intervention on Medical and Dental Claims in People With Diabetes
Overview
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
- Behavioral Diabetes 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. - Drug Stannous Fluoride Dentifrice
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. - Drug Cetylpyridinium 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.
Primary outcome measures
- Dental Claims [Time frame: 12 months]
Secondary outcome measures (1)
- Product usage [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Decentralized Site - Virtual/Remote (NY, USA) — Long Island City
Identifiers
NCT: NCT07619729 · CRO-2026-05-GoMo-Diabetes-GJ