Phase 3- Clinical Trial on Children. PROTOCOL 465-549
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Retention of acetal crowns for primary molars
研究概览
简要总结
Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly broken down primary teeth since 1950. They are generally considered more expedient to place than large multi-surface amalgam or composite restorations and have a longer life. They have been used successfully in clinical practice for many years and have presented little in the way of adverse events. The major drawback is the poor esthetics along with lingering concerns over potential health hazards associated with the nickel content. Several attempts have been made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and occlusal surfaces and substituting composite resin for the entire crown, but to date none of these approaches have been very successful.
Acetal resin has been used in a number of applications in medicine and dentistry, and recently has met with early success when tested as a substitute for stainless steel crowns. It has a number of excellent physical and mechanical properties including a low coefficient of friction, good wear resistance, high fatigue resistance, good impact strength and resistance to creep.
The purpose of this trial is to compare the clinical performance of preformed acetal resin crowns and preformed stainless steel crowns.
2.0 OBJECTIVES
The objective of this study is to compare the clinical performance of acetal resin crowns with preformed stainless steel crowns when used to restore primary molar teeth.
详细描述
STUDY POPULATION
A minimum of 25 subjects contributing a minimum of 40 acetal crowns ( on primary molar teeth will be recruited from the patient pool of the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon and enrolled into the study. A maximum of four crowns will be placed in any subject. It is estimated that it will take approximately 14 weeks to place all crowns and complete the baseline examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of record at the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon
- •Ages 3-8 (inclusive)
- •In need of at least one Stainless Steel Crown on either a first or second primary molar
排除标准
- •Medically compromising condition
- •Informed consent not given
- •Teeth with proximal space closures of sufficient magnitude to preclude placement of a test crown
结局指标
主要结局
Retention of acetal crowns for primary molars
时间窗: two years
Number of patients with adverse events
次要结局
- Color stability of acetal crown(two years)
研究者
Uri Zilberman
Head of Dentistry Unit
Barzilai Medical Center