Resin Infiltration vs Ionomer-Based Fluoride Varnish for the Prevention of Post-Eruptive Breakdown in Molars With Mild MIH

Universidad Autonoma de San Luis Potosí17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Molar Hypomineralization, Incisor

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Post-eruptive breakdown (PEB)

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.

Time frame: 6 months