Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Jordan
About this trial
To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant.
To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions.
First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns.
Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Partially edentulous area with suitable restorative space more than 5.5 mm
At least 18 years of age
Opposing natural teeth or fixed restorations supported by teeth or implants.
Generally good health (ASA I, ASA II)
Disqualifiers
Inability to provide consent.
Temporomandibular disorders
Smoking of more than 10 cigarettes per day
Untreated caries or periodontal disease of remaining dentition
Trial design
Design model
Parallel
Treatments tested in this trial
Graded Zirconia Crown
Other interventionmonolithic implant supported crown
Conventional Zirconia Crown
Other interventionmonolithic implant supported crown
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Graded monolithic Zirconia CrownsExperimental treatment 1 intervention
Group B: Conventional monolithic Zirconia CrownsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Technical & Biological Outcomes
The abutments and restoration will be evaluated clinically by two blinded investigators, according to the modified United States Public Health Service (USPHS) criteria USPHS criteria involve four Scales: Alpha, Bravo, Charlie, Delta The criteria of evaluation include: Restoration fracture, Abutment Fracture, Loosening of the restoration, Screw-access hole restoration, Occlusal Wear, Anatomical Form, Color match, Proximal contact, Occlusal Contact, Marginal Fit, Periodontal parameters.
Time frame
Baseline, 6 months, 12 months2
Survival and Success rate
All patients will be evaluated for success and survival of restorations at 6 months and 1 year after placement of the restorations (Follow-ups). The success rate is defined as the number of restorations that did not change over time. The survival rate is defined as the number of restorations that did not require replacement.
Time frame
6 months, 12 months3
Patient reported outcomes
Patient satisfaction in terms of the shape and shade of the crown, their ability to chew (function) and floss (proximal contact) and their overall satisfaction with the restoration provided will be assessed by a questionnaire based on a five-grade ordinal category scale (extremely satisfied, satisfied, neutral, dissatisfied and extremely dissatisfied). Each patient was asked to fill out the questionnaire themselves to ensure as little bias as possible.
Time frame
6 months, 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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