Molar Incisor Hypomineralization
Conditions
Brief 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.
Interventions
DRUGResin 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.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Color Improvement and Lesion Masking Effect | Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enamel Surface Integrity | Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment | Structural stability/breakdown of the treated enamel surfaces. |
| Tooth Hypersensitivity Assessed by Visual Analog Scale (VAS) | Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment | 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). |
| Tooth Hypersensitivity Assessed by Schiff Cold Air Sensitivity Scale (SCASS) | Baseline, 1 month, 3 months, 6 months, and 12 months post-treatment | 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). |
Countries
Vietnam
Outcome results
None listed