Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Survival rates of the direct restorative treatment
研究概览
简要总结
The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.
详细描述
For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children and/or parents who agree in participate of the study
- •children were born and living in Araraquara, SP, Brazil
- •presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.
排除标准
- •children and/or parents who do not agree in participate of the study
- •first permanent molars with enamel malformation associated with syndromes,
- •dental fluorosis,
- •first permanent molars with destroyed crowns,
- •imperfect amelogenesis
- •fixed orthodontic appliances.
结局指标
主要结局
Survival rates of the direct restorative treatment
时间窗: 6 months
次要结局
未报告次要终点
研究者
Juliana Feltrin de Souza Caparroz
Juliana Feltrin de Souza
Universidade Federal do Paraná