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

NCT07443878 | Completed DMC

• 1 other identifier: CEI-FE-066-023
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Molar Hypomineralization, Incisor; Preventive Dentistry

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Resin Infiltrant (Icon®)

EXPERIMENTAL

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)

Ionomer-Based Fluoride Varnish (Clinpro XT®)

ACTIVE COMPARATOR

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)

Interventions

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.

Resin Infiltrant (Icon®)

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.

Ionomer-Based Fluoride Varnish (Clinpro XT®)

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, Mexico

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a split-mouth study design where each participant receives both interventions in different quadrants

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: September 23, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

ME (1)