Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions (NCT07653373) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Enamel Cleaning on a Remineralizing Paste for Hypomineralizated Lesions
Brazil54 participantsStarted 2026-08
Plain-language summary
Molar-incisor hypomineralization (MIH) is a qualitative defect of dental enamel, in which low mineral content and high protein content compromise the effectiveness of remineralizing treatments. Various agents have been used to remove proteins from hypomineralized enamel, such as sodium hypochlorite (NaOCl). Sodium hypochlorite is an antimicrobial irrigant capable of dissolving tissues. CPP-ACPF is used as a remineralizing agent for MIH lesions, it is capable of stabilizing calcium, phosphate, and fluoride ions on the tooth surface, maintaining them in an amorphous form. Therefore, the objective of this study is to evaluate the clinical performance of amorphous calcium fluoride casein phosphate phosphopeptide (CPP-ACPF) dental mousse on deproteinized hypomineralized enamel.
Who can participate
Age range
7 Years – 9 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:
* Children must have at least one permanent molar without MIH, at least two permanent molars with mild MIH lesions (demarcated opacities without structural loss), with or without sensitivity, that are cream-white or yellowish in color and at least 2 mm in diameter. The teeth with lesions may or may not be on the same dental arch.
Exclusion Criteria:
* Children with visible bacterial biofilm, enamel malformations associated with syndromes, amelogenesis imperfecta, or fluorosis, and children who are allergic to milk proteins (casein) will not be eligible to participate in the study.
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.