Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Crown failure
研究概览
简要总结
This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
详细描述
The study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- •reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- •Teeth to be vital and asymptomatic prior to treatment
- •No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
排除标准
- •Devital or sensitive teeth
- •Teeth with prior endodontic treatment of any kind
- •Teeth with a history of direct or indirect pulp capping procedures
- •Patients with significant untreated dental disease to include periodontitis and rampant caries
- •Pregnant or lactating women
- •Patients with a history of allergies to any of the materials to be used in the study
- •Patients unable to return for the recall appointments
研究组 & 干预措施
Tetric CAD Crown
Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
干预措施: Tetric CAD (Device)
结局指标
主要结局
Crown failure
时间窗: from delivery of the crown up to 5 years
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years.
Crown Failure
时间窗: from delivery of the crown up to 5 years
Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years.
次要结局
- Tooth sensitivity(from delivery of the crown up to 5 years)
- Crown loss of retention(from delivery of the crown up to 5 years)
- Margin staining(from delivery of the crown up to 5 years)
- Crown Loss of Retention(from delivery of the crown up to 5 years)
- Tooth Sensitivity(from delivery of the crown up to 5 years)
- Margin Staining(from delivery of the crown up to 5 years)
研究者
Dennis J. Fasbinder, DDS
Clinica Professor
University of Michigan