Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of participants with restoration failure of either material
研究概览
简要总结
The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.
详细描述
In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.
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)
盲法说明
Double blind (Subject, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be older than 18 years of age
- •have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings
- •both study teeth must be vital (tested with cold)
- •both study fillings must be visible on the cheek-side of the tooth.
排除标准
- •do not meet all inclusion criteria
- •are under active orthodontic treatment
- •have severe medical complications
- •have dry mouth
- •have chronic gum disease or poor oral hygiene
- •are unavailable for long term recall (minimum of 2 years required)
- •cannot tolerate the rubber dam
- •have an unstable tooth contacts
- •have severe bruxing or clenching, or are in need of jaw joint therapy
- •are pregnant or breastfeeding.
结局指标
主要结局
Number of participants with restoration failure of either material
时间窗: 2 years
Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure.
次要结局
- Clinical performance score for each restoration(2 years)
- Confirmation of material safety(2 years)
研究者
Adriana Cordero Wilson
Clinical Assistant Professor
Louisiana State University Health Sciences Center in New Orleans