Clinical Evaluation of an Experimental Remineralization Product (NCT06166849) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of an Experimental Remineralization Product
Romania43 participantsStarted 2023-03-28
Plain-language summary
The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.
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:
* At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
* Active caries lesion
* Patient at risk of caries
* Vital teeth
Exclusion Criteria:
* Pregnancy
* Enamel detachment at the site of investigation
* Allergies (DoReMin)
* Chronic diseases
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.