Resin Infiltration Versus Ionomer-Based Fluoride Varnish to Prevent Post-Eruptive Breakdown in Molars With Mild Molar-Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Post-eruptive breakdown (PEB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Resin Infiltrant (Icon®, DMG) (Other)
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
干预措施: Varnish-Modified Glass Ionomer (Clinpro XT®, 3M) (Other)
结局指标
主要结局
Post-eruptive breakdown (PEB)
时间窗: 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.
次要结局
未报告次要终点
研究者
Daniela Guzmán Uribe
Clinical Professor
Universidad Autonoma de San Luis Potosí