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

March 1, 2026 updated by: Daniela Guzmán Uribe, Universidad Autonoma de San Luis Potosí

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico
        • Universidad Autonoma de San Luis Potosí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resin Infiltrant (Icon®)
Participants will receive resin infiltration (Icon®, DMG) on one permanent molar affected by mild MIH. The side (left or right) will be determined by random allocation
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.
Active Comparator: Ionomer-Based Fluoride Varnish (Clinpro XT®)
Participants will receive ionomer-based fluoride varnish (Clinpro XT®, 3M) on the contralateral permanent molar affected by mild MIH
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Nogueira VKC, Soares IPM, Fragelli CMB, Boldieri T, Manton DJ, Bussaneli DG, et al. Structural integrity of MIH-affected teeth after treatment with fluoride varnish or resin infiltration: an 18-month randomized clinical trial. J Dent. 2021;105:103570. doi: 10.1016/j.jdent.2020.103570

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-FE-066-023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Molar Hypomineralization, Incisor

Clinical Trials on Resin Infiltrant (Icon®, DMG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe