Three Approaches of Resin Infiltration for MIH Incisor Opacities (NCT07715370) | Clinical Trial Compass
CompletedNot Applicable
Three Approaches of Resin Infiltration for MIH Incisor Opacities
Egypt63 participantsStarted 2024-07-01
Plain-language summary
Molar incisor hypomineralization (MIH) is a condition which involves enamel hypomineralization of one to four first permanent molars with or without permanent incisors. Affected permanent incisors present with demarcated enamel opacities which cause esthetic and psychological problems to patients with MIH. Microabrasion and etch-bleach surface treatment can provide easier, conservative, and biologically driven treatment approach compared to macroabrasion prior to prolonged resin infiltration for treating enamel opacities in incisors of MIH patients.
The aim of this study is to evaluate the effect of microabrasion and etch-bleach surface treatment compared to macroabrasion prior to prolonged resin infiltration on esthetic appearance of permanent incisors affected with demarcated enamel opacities in MIH patients.
Who can participate
Age range
8 Years – 14 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:
* Cooperative healthy male and female children aged 8 to 14 years.
* MIH diagnosed patients according to the criteria of European Academy of Pediatric Dentistry (EAPD) with demarcated enamel opacity that caused esthetic discomfort to them and their guardian, involving at least one maxillary or mandibular permanent incisor.
* At least one-third of the affected tooth crown should be visible in the oral cavity.
Exclusion Criteria:
* Children with behavioral, cognitive, physical, or medical conditions that will affect or complicate the treatment.
* Other developmental defects of dental enamel rather than MIH (i.e. dental fluorosis, enamel hypoplasia, amelogenesis imperfecta or Turner's tooth)
* Loss of tooth structure due to post-eruptive enamel breakdown or caries.
* Periodontal disease of the affected tooth.
* Incisors previously subjected to trauma that might lead to loss of tooth structure or compromise the pulp vitality.
* Previous preventive, restorative or orthodontic treatment on the affected tooth.
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.