Molar Hypomineralization, Incisor
Conditions
Keywords
Molar Hypomineralization, Incisor, Preventive Dentistry
Brief summary
round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH). Research Question: Can resin infiltration effectively prevent post-eruptive enamel breakdown in permanent molars with mild MIH compared to an ionomer-based fluoride varnish? Methodology: The researchers will compare the resin infiltrant Icon® (DMG) with Clinpro XT® Varnish (3M) to prevent post-eruptive enamel breakdown in permanent molars with mild MIH. Participants: Children aged 6 to 13 years presenting at least two permanent molars affected by mild MIH, with no prior structural loss or previous dental treatment. Requirement to attend follow-up evaluations at 15 days, 1 month, 3 months, and 6 months.
Interventions
OTHERResin Infiltrant (Icon®, DMG)
Application of a low-viscosity light-cured resin (Icon®) after surface pretreatment with 15% hydrochloric acid gel (Icon-Etch). The resin is applied to the affected permanent molar to seal the porous enamel and prevent post-eruptive breakdown.
OTHERVarnish-Modified Glass Ionomer (Clinpro XT®, 3M)
Application of a site-specific, light-cured varnish-modified glass ionomer (Clinpro XT®). It provides a physical barrier and long-term fluoride release to strengthen the hypomineralized enamel.
Sponsors
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a split-mouth study design where each participant receives both interventions in different quadrants
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Participants with two or more permanent molars affected by mild Molar Incisor Hypomineralization (MIH), graded according to EAPD criteria. * Mild MIH-affected permanent molars with no history of prior dental treatment. * Fully erupted or partially erupted permanent molars * Permanent molars with MIH presenting ICDAS code 0, 1, or 2 (non-cavitated caries lesions). * Systemically healthy patients. * Patients (and/or legal guardians) who agree to participate, providing written informed consent and child assent.
Exclusion criteria
* Presence of only one permanent molar affected by MIH. * Permanent molars with MIH that already present post-eruptive breakdown (PEB). * Permanent molars with caries lesions classified as ICDAS 3 or higher. * Enamel defects of other etiologies in permanent molars (e.g., Amelogenesis Imperfecta, fluorosis, or hypoplasia). * Patients with systemic diseases or lack of cooperation during dental treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-eruptive breakdown (PEB) | 6 months | The primary outcome is the occurrence of Post-Eruptive Breakdown (PEB), defined as the loss of enamel structural integrity resulting in cavitation or a clinical 'step-off' appearance within the hypomineralized area of the permanent molar. This will be recorded as a dichotomous variable (Presence/Absence) based on the European Academy of Paediatric Dentistry (EAPD) diagnostic criteria. |
Countries
Mexico
Outcome results
None listed