An interventional study of Resin infiltration and Fluoride Varnishes in Molar Incisor Hypomineralization, sponsored by Hanoi Medical University. Recruiting at 3 sites in Vietnam. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Hanoi Medical University · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Molar Hypomineralization; 43 are open to participants now.
This study's planned enrollment of 150 is above the median of 52 across 99 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Hanoi Medical University is the lead sponsor of 53 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Permanent incisors affected by mild molar-incisor hypomineralization (MIH) treated with 5% sodium fluoride varnish (NaF) application following standard prophylaxis and drying protocols.
Drug: Fluoride Varnishes
Incisors with mild MIH treated with resin infiltration (Icon, DMG, Germany) following standard etching, drying, and light-curing protocols.
Drug: 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.
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.
Color Improvement and Lesion Masking Effect
Assessment of esthetic improvement and color masking of hypomineralized enamel lesions using digital spectrophotometry or standardized visual aesthetic indices (e.g., VAS / Color Difference delta E).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Enamel Surface Integrity
Structural stability/breakdown of the treated enamel surfaces.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Visual Analog Scale (VAS)
Tooth hypersensitivity is self-reported by the subject using a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10 following thermal/air stimulation. Score 0 indicates "no pain or discomfort" and score 10 indicates "worst possible pain". Higher scores indicate greater hypersensitivity (worse outcome).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Tooth Hypersensitivity Assessed by Schiff Cold Air Sensitivity Scale (SCASS)
Tooth hypersensitivity is evaluated in response to a 1-second blast of cold air from a dental air syringe applied to the affected tooth surface. Sensitivity is scored using the Schiff Cold Air Sensitivity Scale ranging from 0 to 3: 0 = Tooth/subject does not respond to air stimulus; 1 = Tooth/subject responds to air stimulus but does not request discontinuation; 2 = Tooth/subject responds to air stimulus and requests discontinuation or moves from stimulus; 3 = Tooth/subject responds to air stimulus, considers stimulus painful, and requests discontinuation. Higher scores indicate greater hypersensitivity (worse outcome).
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment
Plan to share: No
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Hanoi Medical University