A Prospective Clinical Trial Evaluating Outcomes of Surveyed Zirconia Crowns (NCT06564337) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Clinical Trial Evaluating Outcomes of Surveyed Zirconia Crowns
50 participantsStarted 2025-01-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival
Timeframe: study follow up- every year for 3-5 years
2
Biological Complications
Timeframe: study follow up- every year for 3-5 years
3
Technical Complications
Timeframe: study follow up- every year for 3-5 years
4
Success
Timeframe: study follow up- every year for 3-5 years
5
Other complications
Timeframe: study follow up- every year for 3-5 years