Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Survival and success rates
研究概览
简要总结
The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.
The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
详细描述
A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One posterior tooth (molar or premolar) to be crowned,
- •Vital abutments or abutments with sufficient endodontic treatment
- •Abutment not crowned previously
- •Periodontally healthy abutments with no signs of bone resorption or periapical disease --
- •Adequate occlusogingival height
- •Stable occlusion, and the presence of natural dentition in the antagonist arch.
排除标准
- •Patients who present reduced crown length (less than 3 mm occlusogingival height
- •Poor oral hygiene, high caries activity, active periodontal disease or bruxism.
结局指标
主要结局
Survival and success rates
时间窗: 3 years
Survival and success rates with Kaplan Meier method
次要结局
- Quality of restorations at 1 year(1 year)
- Plaque Index (PI) at 2 years(2 years)
- Quality of restorations at 3 years(3 years)
- Plaque Index (PI) at 1 year(1 year)
- Probing depth at 1 year(1 year)
- Margin stability at 3 years(3 years)
- Quality of restorations at baseline(Baseline)
- Plaque Index (PI) at baseline(Baseline)
- Probing depth at 3 years(3 years)
- Quality of restorations at 2 years(2 years)
- Gingival Index (GI) at 1 year(1 year)
- Gingival Index (GI) at 2 years(2 years)
- Probing depth at 2 years(2 years)
- Patient satisfaction at 3 years(3 years)
- Gingival Index (GI) at baseline(Baseline)
- Plaque Index (PI) at 3 years(3 years)
- Probing depth at baseline(Baseline)
- Gingival Index (GI) at 3 years(3 years)
- Margin stability at baseline(Baseline)
- Margin stability at 1 year(1 year)
- Margin stability at 2 years(2 years)