Randomized Controlled Clinical Trial of a New NuSmile ZR Esthetic Primary Molar Crown
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Assessments of the SSC and ZR Crown
研究概览
简要总结
The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
详细描述
The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 3 and 7 years of age
- •Have a minimum of two primary molar teeth, requiring crowns
- •Have a parent or guardian capable of giving written informed consent
- •Have study teeth in occlusion and in contact with adjacent teeth
- •Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.
排除标准
- •Tooth is considered to be within 36 months of exfoliation
- •They have a severe / serious childhood illness that requires frequent hospitalization
- •They have poor general health
- •They have juvenile periodontitis
- •Patient is unable to return for evaluations / study recalls
结局指标
主要结局
Assessments of the SSC and ZR Crown
时间窗: At Baseline
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match, marginal integrity.
Assessments of the SSC and ZR Crown at 6 months
时间窗: 6 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 12 months
时间窗: 12 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 18 months
时间窗: 18 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of the SSC and ZR Crown at 24 months
时间窗: 24 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crown at 36 months
时间窗: 36 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
Assessments of SSC and ZR Crowns at 48 months
时间窗: 48 month visit
Clinically evaluate both the stainless steel crown and ZR crown for wear, gingival health, crown performance, color match and marginal integrity.
次要结局
未报告次要终点