Clinical Performance of Chairside CAD/CAM Restorations Using a New Adhesive Cement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
研究概览
简要总结
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of a resin cement for chairside CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays will be adhesively bonded using a selective enamel etch technique with an adhesive.
Full contour zirconia crowns will be cemented using a self-adhesive resin cement.
详细描述
A wide variety of restorative materials are available for dental restorations. The most popular current materials include glass ceramics and full contour zirconia. Glass ceramic materials are generally preferred for their high translucency mimicking enamel-like esthetics of natural teeth and zirconia is preferred for high strength applications. Both of these materials are available for clinical treatment using chairside CAD/CAM technology.
The introduction of an induction sintering oven (SpeedFire oven/Dentsply Sirona) opened the opportunity for chairside full contour zirconia crowns by decreasing sintering times for zirconia to under 30 minutes. 3M Chairside Zirconia (3M) was marketed in 2019 and offers improved esthetics and high strength for monolithic zirconia restorations with an efficient processing time.
This investigation will be a longitudinal clinical trial to study the long-term clinical performance of CAD/CAM restorations. Lithium disilicate chairside CAD/CAM onlays (IPS emaxCAD/Ivoclar) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (3M) and a resin cement (3M). Full contour zirconia crowns (3M Chairside Zirconia/3M) will be cemented using a self-adhesive technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject in need of crown and/or onlay restoration
- •Subject age 18 or above
- •Subject with healthy / treated periodontal status (max. degree of movement 1)
- •Subject agrees to participate in the study and signed informed consent and HIPAA form
排除标准
- •Devital or sensitive teeth
- •Teeth diagnosed with symptoms of incomplete tooth fracture
- •Teeth with prior endodontic treatment of any kind
- •Teeth with a history of direct or indirect pulp capping procedures
- •Subjects with uncontrolled bruxism or parafunctional habits
- •Subject has known allergies to any product used in this study
- •Subject will not be available for the study duration
- •Subjects with significant untreated dental disease to include periodontitis and rampant caries
- •Pregnant or lactating women
结局指标
主要结局
Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Retention Scores]
时间窗: 3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years
Retention. Evaluations according to FDI World Dental Federation criteria (Hickel et al., 2010) \[5b.1 Restoration in place; 5b.5 Complete loss of restoration\] Functional property (retention) assessed by visual and/or tactile assessment by two independent examiners.\]
次要结局
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Material Fracture Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Distal Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Mesial](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Point - Mesial Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Approximal Anatomical Contact Form - Distal Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Biologic Properties of Restorations (Onlays and Crowns) [Recurrence of Caries, Erosion, Abfraction Scores](3 years with assessments at 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Occlusal Contour and Wear Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Functional Long-term Properties Clinical Performance of Restorations (Onlays and Crowns) [Marginal Adaptation Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Short-term Post-operative Sensitivity (Onlays and Crowns)(up to 4 weeks after baseline with weekly assessments or until the restoration is reported asymptomatic)
- Esthetic Properties of Restorations (Onlays and Crowns) [Surface Luster Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Gingival Index (Onlays and Crowns)(3 years with assessments at 6 months, 1 year, 2 years, and 3 years)
- Plaque Index (Onlays and Crowns)(3 years with assessments at 6 months, 1 year, 2 years, and 3 years)
- Esthetic Properties Clinical Performance of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Biologic Properties of Restorations (Onlays and Crowns) [Post-operative Sensitivity](3 years with assessments at 6 months, 1 year, 2 years, and 3 years)
- Esthetic Properties of Restorations (Onlays and Crowns) [Surface Staining Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Esthetic Properties of Restorations (Onlays and Crowns) [Margin Staining Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Esthetic Properties of Restorations (Onlays and Crowns) [Color Match and Translucency Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)
- Esthetic Properties of Restorations (Onlays and Crowns) [Aesthetic Anatomical Form Scores](3 years with assessment visits at baseline, 6 months, 1 year, 2 years, and 3 years)