CompletedNot Applicable

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

Mexico17 participantsStarted 2023-09-23

Plain-language 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.

Who can participate

Age range6 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Post-eruptive breakdown (PEB)

Timeframe: 6 months

Trial details

NCT IDNCT07443878

SponsorUniversidad Autonoma de San Luis Potosí

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30