A Prospective Clinical Trial Evaluating Outcomes of Surveyed Zirconia Crowns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeena DSouza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
RPD abutment teeth which may benefit from full coverage due to large restorations.
Posterior endodontically treated teeth with inadequate marginal ridge support and
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Surveyed zirconia crown
DevicePatient recruitment will be from the patient population that presents to the undergraduate dental clinic requiring removable dental prosthesis (RPD) to replace missing teeth. Selection of abutment teeth for zirconia surveyed crowns will be similar to that currently utilized when selecting RPD abutments to be restored with either porcelain fused to metal or full metal surveyed crowns for tissue and tooth supported RPD's.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients recruited for interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Survival
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.
Time frame
study follow up- every year for 3-5 years2
Biological Complications
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.
Time frame
study follow up- every year for 3-5 years3
Technical Complications
Technical failures will be recorded when * the zirconia crown fractures or * needs to be replaced because of inadequate fit.
Time frame
study follow up- every year for 3-5 years4
Success
Success will be recorded as all surviving crowns with no clinical complications.
Time frame
study follow up- every year for 3-5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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