Efficacy and Safety Evaluation of Anti-Caries Varnish (NCT04947527) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Evaluation of Anti-Caries Varnish
United States Minor Outlying Islands274 participantsStarted 2022-06-04
Plain-language summary
The purpose of the study is to determine the efficacy \& safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are:
1\) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.
Who can participate
Age range
10 Months – 20 Months
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
. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
. The subject is a 6-24 months at the time of enrollment.
. The subject must be in good general health as evidenced by parent report.
. The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.
Exclusion criteria
. Previous treatment with fluoride varnish
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.
What they're measuring
1
Caries Increment
Timeframe: 24 months post baseline
2
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces
. Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit.
. Visible cavities (d2-4)
. Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared)
. Parent anticipates the child will move from Pohnpei during the next 2 years.