A Prospective Clinical Trial Evaluating Outcomes of Surveyed Zirconia Crowns on Removable Partial Denture Abutment Teeth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Biological Complications
研究概览
简要总结
Zirconia has shown to be a suitable substitute for metal ceramic crowns when comparing survival, biological and technical complications. Evidence demonstrating the outcomes of surveyed zirconia crowns on removable partial denture abutments is unavailable. Zirconia as a substitute for metal ceramic is being currently used for fabricating surveyed crowns although quantitative data evaluating its efficacy is sparse. The purpose of this prospective clinical trial is to evaluate clinical outcomes when zirconia is used as a full coverage restoration on removable partial denture abutments. The study will be designed as a 3-5 year prospective observational trial in the University of Toronto undergraduate clinic in a controlled environment. Outcomes measures will include survival, biological and technical complications. Descriptive statistics will be used to summarize patient characteristics and outcomes and for categorical variables frequency and percentages will be reported. A level of significance 0.05 will be used for inferential analysis, with p-values < 0.05 reported as statistically significant. It is expected that zirconia will demonstrate similar outcomes to traditional metal ceramic surveyed crowns.
详细描述
Research data on the survival of zirconia crowns as RPD abutments is limited although anecdotally these are being used regularly by dentists in clinical practice. To our knowledge a clinical trial evaluating the outcomes of surveyed monolithic zirconia crowns as RPD abutments has not been investigated previously. We propose to evaluate the outcomes of surveyed zirconia crowns as RPD abutments in a prospective trial and compare the survival, biological and technical complications with alternative materials historically used for surveyed crowns.
Aims of Project
- To evaluate biological and technical complications of surveyed zirconia crowns on RPD abutments for 3- 5 years following insertion.
- To evaluate survival of surveyed zirconia crowns for 3- 5 years following insertion.
Materials and Methods
Research Design and Overview: The study will be designed as a 3-5 year prospective observational trial in the University of Toronto undergraduate clinic in a controlled environment where procedures are standardized for case selection and execution. All patients requiring surveyed crowns in the academic years 2024 and 2025 will be approached to participate in the trial. Patients will be recalled every year for 3-5 years following insertion and a check list will be used to assess the pre insertion and outcome variables. Clinical coordinators supervising students and clinical examiners performing outcome assessments at yearly follow up will be trained and their measurements calibrated for inter and intra observer variability to ensure uniformity. The research proposal will be submitted to the University Research Oversight and Compliance office for ethics approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion criteria: Patient recruitment will be from the adult patient population that presents to the undergraduate/graduate prosthodontic dental clinic requiring new tooth or tissue supported removable cast dental prostheses to replace missing teeth for the following situations:
- •In Kennedy Class 1 and 2 tisuue supported RPD's-Terminal abutments 3,4,5,6
- •In Kennedy Class 3 and 4 tooth supported RPD's- any abutment teeth selected will need to be documented if selected as abutments for a surveyed crown.
- •Selection of abutment teeth for zirconia surveyed crowns will be similar to that currently utilized when selecting cast RPD abutments to be restored with either porcelain fused to metal or full metal surveyed crowns for tissue and tooth supported cast RPD's. Identifiable data will include:
- •RPD abutment teeth which may benefit from full coverage due to large restorations.
- •Posterior endodontically treated teeth with inadequate marginal ridge support and
- •Abutment teeth which require axial modification for RPD retentive and or stability elements.
- •In situations where esthetic improvement is desirable
- •Reasons for selection wil be documented.
排除标准
- •Crowns that need to be splinted; patients that decline a surveyed crown; patients under the age of 18 years; patients that decline to participate in the study.
结局指标
主要结局
Biological Complications
时间窗: study follow up- every year for 3-5 years
Biological failures will be recorded when the tooth is no longer present in the mouth either because of * tooth or core fracture rendering the tooth non restorable, * or the tooth extracted because of caries, infection or periodontal disease.
Success
时间窗: study follow up- every year for 3-5 years
Success will be recorded as all surviving crowns with no clinical complications.
Technical Complications
时间窗: study follow up- every year for 3-5 years
Technical failures will be recorded when * the zirconia crown fractures or * needs to be replaced because of inadequate fit.
Other complications
时间窗: study follow up- every year for 3-5 years
Not listed above
Survival
时间窗: study follow up- every year for 3-5 years
A. Survival will be recorded as the tooth with the crown still in function with or without 'clinical complications' during and up to the end of follow up. These will include but are not limited to * occlusal adjustments, * follow up sensitivity, * open margins, * recurrent decay, * infection, * endodontic treatment or retreatment, * chipping of ceramic, * recementation, * non healing endodontic lesion, * bone loss and associated periodontal problems.
次要结局
未报告次要终点
研究者
Neena DSouza
Co-Investigator
University of Toronto