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临床试验/NCT04929782
NCT04929782已完成不适用

Clinical Evaluation of Giomer and Resin-based Fissure Sealants Performed in Permanent Molar Teeth Affected by Molar-Incisor Hypomineralization

Hacettepe University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Clinical performance evaluation using USPHS Criteria

研究概览

简要总结

The objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (FPMs) affected by MIH.

详细描述

One-hundred FPMs with MIH which were indicated for non-invasive fissure sealant were selected in 39 children (between 6-12 years). Using a split mouth design, the FPMs were randomized into two groups; Group 1: resin sealant (Conceal F); Group 2: giomer sealant (BeautiSealant) and dental isolation device was used during the procedure (Mr. Thursty). Clinical evaluation was performed by two blinded examiners using the United States Public Health Service (USPHS) criteria to assess anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months. Statistical analysis was performed using SPSS 20.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The association between independent variable (groups) and dependent variable (USPHS scores) was evaluated with Fisher's exact test. The crosstabulation of the categorical data regarding the groups were analyzed with chi-square test or Fisher's exact test. The Log-rank test and Kaplan-Meier analysis were used to calculate and compare the cumulative survival rates of the sealants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The follow-up evaluations by using the modified United States Public Health Service (USPHS) criteria were completed independently by two calibrated investigators who were blinded to the groups and a forced consensus was sought in any case of disagreement.

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination
  • Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
  • Presenting at least two FPMs that were fully erupted and indicated for non-invasive fissure sealant.
  • The FPMs with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk

排除标准

  • Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
  • Enamel defect due to a condition other than MIH

结局指标

主要结局

Clinical performance evaluation using USPHS Criteria

时间窗: 12 months

Clinical evaluation was performed by two blinded examiners in accordance with the modified-USPHS criteria, to assess anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beste Ozgur

Asst. Prof.

Hacettepe University

研究点 (2)

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