NCT07443878

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Universidad Autonoma de San Luis Potosí · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Molar Hypomineralization, Incisor

Interventions

Type	Name	Description
OTHER	Resin 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.
OTHER	Varnish-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.

Timeline

• Start date: 2023-09-23
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2026-03-02
• Last updated: 2026-03-04

Locations

1 site across 1 country: Mexico