Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes (NCT07619729) | Clinical Trial Compass
By InvitationPhase 4
Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes
United States10,000 participantsStarted 2026-05-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial focuses on people with both Type 2 diabetes and gum or tooth problems, should I get a full dental evaluation before we discuss whether this study could be relevant to my situation?
2This is a Phase 4 trial, which means the behavioral intervention being tested has already been through earlier safety reviews — but what do we actually know so far about whether improving oral health habits has shown any meaningful impact on diabetes management in studies like this?
3The trial is measuring success through dental insurance claims, which seems like an indirect measure — can you help me understand what that tells us about whether my oral health is actually improving, versus just whether I'm visiting the dentist more often?
4Since enrollment is by invitation only, how would I or my care team find out if I'm eligible to be considered, and who is doing the inviting — is it through my insurance plan, my primary care doctor, or my dentist?
5If I don't end up being part of this trial, are there already established guidelines you'd recommend for managing my gum disease and cavity risk as part of my overall Type 2 diabetes care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.