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Molar-Incisor Hypomineralization and Resin Infiltration

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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 ΔE, 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 topical fluoride varnish application or observation/untreated controls) to quantify improvements in color stability, remineralization, and defect dimensions. Participating pediatric subjects will undergo comprehensive oral examinations to index MIH severity on first permanent molars and incisors, alongside standardized questionnaire-based interviews with guardians to record medical history. Children presenting with mild incisor defects enrolled in the clinical trial will receive treatment with resin infiltration or comparative controls, followed by standardized digital photography and spectrophotometric color assessment (using the VITA Easyshade V device), with structured post-operative follow-up evaluations scheduled at baseline 1 month, 2nd month, 3rd month, 6th month, and 12th month to measure long-term treatment longevity and outcomes.
Trial Details
NCT Number NCT07873268
Lead Sponsor Hanoi Medical University
Conditions
(from sponsor)
Molar Incisor Hypomineralization
Related terms Molar Hypomineralization
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov