Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
研究概览
简要总结
The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.
The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.
详细描述
Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
- •Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
- •Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
- •Children who haven't any systemic disease that prevents the application,
- •Cooperative children who allowed the clinical applications.
排除标准
- •Teeth with proximal and initial caries,
- •Teeth with applied fissure sealant,
- •Teeth with developmental defects such as hypoplasia and restorations,
- •Non-cooperative children who don't allow the clinical applications,
- •Children and parents who denied the participation in the follow-up appointments.
结局指标
主要结局
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
时间窗: 18 months after the clinical applications
The primary outcome of the study was the assessment of clinical retention rates at 18th months.
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
时间窗: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
时间窗: 18 months after the clinical applications
The primary outcome of the study was the assessment of secondary caries rates at 18th months.
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
时间窗: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
次要结局
- The assessment of remineralization capacity using DIAGNOdent device(18 months after the clinical applications)
研究者
Merve AKCAY
Assoc. Prof. Dr.
Izmir Katip Celebi University