Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Total Amount of Chipping
研究概览
简要总结
In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?
详细描述
Study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic with buccal veneer (MZ) or full contour monolithic (FCMZ) ) and zirconia veneered with feldspathic (PVZ) in full-mouth type of rehabilitations (maxilla and mandible).
In a private clinic we will record the behavior, regarding prosthodontic and biological complications in different groups (MZ vs FCMZ vs PVZ) after at least 1 year in function.
We will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter.
Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxilla and/or Mandible Implant full-mouth restoration
- •Monolithic ceramic or zirconia-feldspathic restoration
- •be at least 18 years of age;
- •present no systemic or local absolute contraindications for endosseous implant placement;
- •at least 1 Year Follow-up
排除标准
- •the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
- •Not full mouth rehabilitation
研究组 & 干预措施
Monolithic Zirconia with Buccal Veneer (MZ)
Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers
干预措施: Dental Implant (Device)
Monolithic Zirconia with Buccal Veneer (MZ)
Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers
干预措施: Monolithic Zirconia (MZ) (Device)
Monolithic Zirconia full-contour (FCMZ)
Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer)
干预措施: Dental Implant (Device)
Monolithic Zirconia full-contour (FCMZ)
Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer)
干预措施: Monolithic Zirconia (FCMZ) (Device)
Zirconia-Feldspathic (PVZ)
Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
干预措施: Dental Implant (Device)
Zirconia-Feldspathic (PVZ)
Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
干预措施: Zirconia-Feldspathic (PVZ) (Device)
结局指标
主要结局
Total Amount of Chipping
时间窗: at least 1-Year post-insertion
measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to last follow-up visit Primary outcomes are defined as survival and success rates of the final prosthesis. For evaluation of these outcomes, an analysis variable will be used (Mendez Caramês et al., 2016): if no alterations are present, the prosthesis will be recorded as "Alpha"
Number of Small Complications
时间窗: at least 1-year post-insertion
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up visit It is determined that if the complication was solved in the dental chair is considered a Small complication/minor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-"Bravo" classification will be attributed
Number of Big Complications
时间窗: at least 1-Year post Insertion
Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up. It is determined that if the complication was solved in the dental laboratory is considered a big complication/major chipping - a "Charlie" classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention;
Number of prosthesis failures
时间窗: at least 1-year post insertion
a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis
次要结局
- Biological complications(at least 1-Year post insertion)
