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Molar-Incisor Hypomineralization and Resin Infiltration

RecruitingNAAges 7 Years - 11 YearsAllHanoi Medical University
NCT07873268 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

This dual-design study-encompassing a cross-sectional descriptive phase and a controlled clinical trial-aims to investigate the prevalence and associated risk factors of Molar Incisor Hypomineralization (MIH), while evaluating the therapeutic efficacy of resin infiltration (ICON) for treating mild MIH lesions in permanent incisors among school children aged 7 to 11 years across selected primary schools in Northern Vietnam. The primary research questions seek to delineate the current epidemiological profile of MIH alongside its pre-, peri-, and postnatal biological determinants, while assessing the longitudinal clinical outcomes of resin infiltration (ICON) regarding color change ฮ”E, lesion depth penetration, and aesthetic restoration compared to control groups. In the interventional phase, outcomes of the resin infiltration cohort will be evaluated against control protocols (such as topi

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Children aged 7 to 11 years. * Children diagnosed with mild Molar-Incisor Hypomineralization (MIH) according to EAPD criteria on permanent incisors. * Permanent incisors with intact anatomical shape, showing smooth enamel surfaces or minor defect depth without post-eruptive enamel breakdown (PEB). * Children and parents/guardians willing to participate and sign the informed consent form. Exclusion Criteria: * Children with severe MIH lesions accompanied by post-eruptive enamel breakdown (PEB), atypical restorations, or dental caries. * Permanent incisors with developmental anomalies, fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta, or severe enamel hypoplasia. * Teeth undergoing active orthodontic treatment or presenting with fixed orthodontic appliances. * Non-vital teeth, teeth with symptoms of pulpitis, apical periodontitis, or history of endodontic treatment. * Children with systemic diseases, chronic physical/mental conditions, or severe uncooperative behavior during dental procedures.
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What it tests

  • Resin infiltration
  • Fluoride Varnishes
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Where

3 sites
Hanoi Medical University
Hanoi, Vietnam
National Institute Of Hygiene And Epidemiology
Hanoi, Vietnam
National of Odonto-Stomatology, Hanoi
Hanoi, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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