Survival of Sealants in Molars Affected by Molar-Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- clinical survival of the sealants
研究概览
简要总结
Aim: To evaluate the clinical survival of fluoride sealants applied in first permanent molars affected by Molar-Incisor Hypomineralization (MIH).
Material and Methods: For this case control study, it was selected 41 first permanent molars of the 21 children aged 6-8 years. MIH was classified by one calibrated examiner (kappa 0.80) according severity of the MIH lesion (EAPD, 2003). Inclusion criteria were FPM with MIH or sound (without MIH), fully erupted, and with sealant treatment indication.
The FPMs were assigned into two groups: G1 - Control group and G2 - MIH group. Both group teeth were treated with sealant application (Fluroshield, NY, USA). Clinical follow-up was performed at baseline, 1, 6, 12 and 18 months for anatomic form, marginal adaptation, retention and presence of caries, according to the United States Public Health Service USPHS-Modified by a blinded examiner (kappa 0.80). The Acturial Method was used to evaluate the survival of sealants. Statistical analysis compared the ratings of each criterion between materials using the Fisher's exact test at a level of significance of 5% (p<0.05).
详细描述
This study was conducted according to the Helsink Declaration. The approval was obtained from the Ethics and Research Committee at Araraquara Dental School, São Paulo, Brazil (protocol #11/09). All parents/guardians of the children signed the informed consent.
Study design:
This case control study included four clinical exams performed in 6 to 8 years-old children that received preventive treated with sealants, divided into 2 groups: G1 - teeth not affect by MIH and G2 - teeth affect by MIH.
Subjects:
The 21 children included in the study had been previously diagnosed with MIH, according to the EAPD criteria. A total of 41 first permanent molars teeth (FPM) were included, being 16 without MIH and 25 with MIH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria were children born and living in Araraquara/SP (Brazil), 6 to 8-year-aged, presenting FPM with MIH or sound, fully erupted, with sealant treatment indication.
排除标准
- •It was excluded teeth with enamel breakdown, enamel tooth malformation linked to syndromes, dental fluorosis, amelogenesis imperfect, fixed orthodontic appliances and patients with bruxism.
结局指标
主要结局
clinical survival of the sealants
时间窗: 18 months
The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores
clinical Survival of the sealants
时间窗: 6 months
The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores
次要结局
未报告次要终点
研究者
Juliana Feltrin de Souza Caparroz
Professor
Universidade Federal do Paraná