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

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.

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Key information

Conditions

Molar Hypomineralization, Incisor Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resin Infiltrant (Icon®, DMG)

Other

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.

Varnish-Modified Glass Ionomer (Clinpro XT®, 3M)

Other

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.

Primary outcomes

Post-eruptive breakdown (PEB)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

Resin Infiltration Versus Ionomer-Based Fluoride Varnish to Prevent Post-Eruptive Breakdown in Molars With Mild Molar-Incisor Hypomineralization

Acronym: MIH

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 2, 2026
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed