Resin Infiltration vs Ionomer-Based Fluoride Varnish for the Prevention of Post-Eruptive Breakdow… (NCT07443878) | Clinical Trial Compass
CompletedNot Applicable
Resin Infiltration vs Ionomer-Based Fluoride Varnish for the Prevention of Post-Eruptive Breakdown in Molars With Mild MIH
Mexico17 participantsStarted 2023-09-23
Plain-language summary
round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH).
Research Question: Can resin infiltration effectively prevent post-eruptive enamel breakdown in permanent molars with mild MIH compared to an ionomer-based fluoride varnish? Methodology: The researchers will compare the resin infiltrant Icon® (DMG) with Clinpro XT® Varnish (3M) to prevent post-eruptive enamel breakdown in permanent molars with mild MIH.
Participants:
Children aged 6 to 13 years presenting at least two permanent molars affected by mild MIH, with no prior structural loss or previous dental treatment.
Requirement to attend follow-up evaluations at 15 days, 1 month, 3 months, and 6 months.
Who can participate
Age range
6 Years – 13 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:
* Participants with two or more permanent molars affected by mild Molar Incisor Hypomineralization (MIH), graded according to EAPD criteria.
* Mild MIH-affected permanent molars with no history of prior dental treatment.
* Fully erupted or partially erupted permanent molars
* Permanent molars with MIH presenting ICDAS code 0, 1, or 2 (non-cavitated caries lesions).
* Systemically healthy patients.
* Patients (and/or legal guardians) who agree to participate, providing written informed consent and child assent.
Exclusion Criteria:
* Presence of only one permanent molar affected by MIH.
* Permanent molars with MIH that already present post-eruptive breakdown (PEB).
* Permanent molars with caries lesions classified as ICDAS 3 or higher.
* Enamel defects of other etiologies in permanent molars (e.g., Amelogenesis Imperfecta, fluorosis, or hypoplasia).
* Patients with systemic diseases or lack of cooperation during dental treatment
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.