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Molar-Incisor Hypomineralization and Resin Infiltration
Sponsor: Hanoi Medical University
Summary
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.
Official title: Prevalence of Molar-Incisor Hypomineralization (MIH) and Effectiveness of Resin Infiltration Treatment
Key Details
Gender
All
Age Range
7 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-10-02
Completion Date
2026-12-10
Last Updated
2026-10-14
Healthy Volunteers
Yes
Conditions
Interventions
Resin infiltration
Isolation \& Prophylaxis: Clean target enamel with fluoride-free paste. Apply rubber dam isolation to protect soft tissues. Acid Etching: Apply Icon-Etch (15% HCl) for 2 minutes with light mechanical agitation. Rinse with water for \> 30 seconds and air-dry. Desiccation \& Optical Verification: Apply Icon-Dry (99% ethanol) for 30 seconds and air-dry. Verify lesion masking visually; repeat etching step if opaque discoloration remains (up to 3 cycles). First Infiltration: Apply Icon-Infiltrant for 3 minutes. Floss interproximally, remove excess resin with gentle air stream, and light-cure for 40 seconds. Second Infiltration \& Finishing: Re-apply Icon-Infiltrant for 1 minute. Remove excess resin, light-cure for 40 seconds, remove isolation, and polish with fine finishing discs.
Fluoride Varnishes
Teeth were cleaned with prophylaxis paste, isolated with cotton rolls, and dried. A thin layer of 5% sodium fluoride (NaF) varnish was applied using a microbrush. Patients were instructed to refrain from eating, drinking, or toothbrushing for at least 4 hours post-treatment to allow optimal remineralization. Follow-up evaluations were conducted at T1, T2, T3, T6, and T12 months.
Locations (3)
Hanoi Medical University
Hanoi, North, Vietnam
National Institute Of Hygiene And Epidemiology
Hanoi, North, Vietnam
National of Odonto-Stomatology, Hanoi
Hanoi, North, Vietnam