Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Short-term Post-operative Sensitivity
研究概览
简要总结
This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two 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)
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
- •at least 18 years of age
- •at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
- •tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
- •No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
- •No more than two restorations will be placed per patient
排除标准
- •Sensitive teeth
- •Teeth with a history of direct or indirect pulp capping procedures
- •Patients with significant untreated dental disease to include periodontitis and/or rampant caries
- •Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
- •Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
- •Patients unable to return for the recall appointments
研究组 & 干预措施
SpeedCEM Plus luted crowns
crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG)
干预措施: Crowns self-adhesively luted (Device)
ZirCAD Cement cemented crowns
crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG)
干预措施: Crowns conventionally cemented (Device)
结局指标
主要结局
Short-term Post-operative Sensitivity
时间窗: 4 weeks
assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"
次要结局
- Quality Criteria (modified FDI criteria)(1 year to 2 years)