Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 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 newly developed high strength ceramic material for crowns. The ceramic 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. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. 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 two groups 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 high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Final surface fabrication was not identified in the treatment process until the crown was milled.
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
结局指标
主要结局
Crown Failure
时间窗: from delivery of the crown up to 3 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 three years.
次要结局
- Crown Loss of Retention(3 years)
- Tooth Sensitivity(3 years)
- Margin Staining(from delivery of the crown up to 3 years)
研究者
Dennis J. Fasbinder, DDS
Clinical Professor
University of Michigan