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

NCT07443878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-03-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universidad Autonoma de San Luis Potosí

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-23
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443878 on ClinicalTrials.gov