Clinical Performance of a Newly Developed Glass Ionomer Restorative Material for Posterior Restorations in an Adolescent Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Restoration survival
研究概览
简要总结
The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.
详细描述
In this post-market longitudinal prospective randomized control clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the efficacy of two high-strength glass ionomer restorative materials for a period of up to 3 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •needs 2 Class II posterior restorations
- •in good health
- •sufficient oral hygiene
- •vital tooth
- •caries in the outer and/or middle third of dentin
- •teeth must have at least one proximal contact to be restored
- •isthmus is less than half the intercuspal distance
- •has one or more enamel-supported antagonistic contact.
- •both study restorations are not in contact with each other
排除标准
- •pregnant or breast feeding
- •erosion/eating disorders
- •bruxism/traumatic malocclusion
- •cusp replacement
- •radiographic bone loss/increased tooth mobility
研究组 & 干预措施
Ketac Universal
Simplified glass ionomer tooth filling
干预措施: Ketac Universal (Device)
Ketac Molar Quick
Glass ionomer tooth filling
干预措施: Ketac Molar Quick (Device)
结局指标
主要结局
Restoration survival
时间窗: 3 years
Survival based on criteria for posterior glass ionomer restorations
次要结局
- Clinical Performance of restoration and restored tooth(3 years)
- Additional Collection of Adverse Events Data(3 years)
研究者
Suzanne E Fournier
Clinical Assistant Professor and Postgraduate Program Director
Louisiana State University Health Sciences Center in New Orleans