Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar… (NCT07504614) | Clinical Trial Compass
By InvitationNot Applicable
Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): a Randomized Clinical Trial
Jordan76 participantsStarted 2025-08-01
Plain-language summary
This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.
Who can participate
Age range
6 Years – 12 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:
* 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
* Non -contributory medical history
* Children must exhibit sufficient cooperation for treatment.
* FPMs status of eruption must allow for proper isolation. Exclusion Criteria:-
* Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
* Carious molars.
* Restored MIH molars.
* Sealed MIH molars.
* MIH molars with extensive enamel breakdown that requires restoration.
* MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis.
* Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis)
* Non-MIH affected molars.
* Parents did not consent for treatment.
* Child not sufficiently cooperative for 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.
What they're measuring
1
Sealant retention
Timeframe: 3,6 and 12 months
2
Marginal integrity
Timeframe: 3,6 and 12 months
3
Marginal discoloration
Timeframe: 3,6 and 12 months
4
Secondary Caries
Timeframe: 3,6 and 12 months
5
Anatomic form
Timeframe: 3,6 and 12 months
6
Surface Texture
Timeframe: 3,6 and 12 months
Trial details
NCT IDNCT07504614
SponsorJordan University of Science and Technology