Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Survival Rate
研究概览
简要总结
The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials.
The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.
详细描述
In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 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
- Double (Participant, Outcomes Assessor)
盲法说明
Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7-16 year old
- •in need of one or two approximal fillings in molars
排除标准
- •known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components
研究组 & 干预措施
ROCK - Single Restorations
ChemFil Rock glassionomer restoration
干预措施: Chemfil ROCK Glassionomer restoration (Device)
Fuji IX GP - Single Restorations
Fuji IX GP Extra glassionomer restoration
干预措施: Fuji IX GP Extra Glassionomer restoration (Device)
Rock AND Fuji - Paired Restorations
ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.
While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.
干预措施: Chemfil ROCK Glassionomer restoration (Device)
Rock AND Fuji - Paired Restorations
ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.
While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.
干预措施: Fuji IX GP Extra Glassionomer restoration (Device)
结局指标
主要结局
Survival Rate
时间窗: 2 years
* Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms. * "Clinically successful" is defined as: no need for replacement due to fracture or retention losses.
次要结局
- Caries Incidence Associated With Restoration(2 years)
- Restored Tooth Performance(2 years)
研究者
Mathilde Peters, DMD, PhD
Professor
University of Michigan