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Comparing the long-term clinical outcome of two designs of high strength ceramic (zirconia) crowns on dental implants

The effect of different design concepts of full contour zirconia (FCZ) ceramic implant restorations on the long-term clinical outcome for patients requiring single tooth replacement: Comparative study of Nobel FCZ- protocol and the Nobel on-1-abutment protocol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000614291
Enrollment
40
Registered
2018-04-20
Start date
2018-06-28
Completion date
Unknown
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to compare the clinical outcome of two different design concepts of full contour monolithic zirconia (FCZ) implant supported restorations. Metal-ceramic restorations are traditional restorations and have been used for many years with success. However, metal-ceramic restorations have multiple steps in the fabrication process, which makes the fabrication process time intensive and technically demanding. With increasing demands for aesthetic and metal-free dentistry, the use of ceramic restorations is increasing. Zirconia is a relatively new material with high strength, good aesthetics and contains no metal. Although zirconia may be a reasonable replacement for traditional metal-ceramic restorations, long-term clinical data is still lacking.

Interventions

Implants will be surgically inserted as per routine surgical procedure. After the integration of the implant (3 months after surgery), the implant will be restored with a crown. Any implant restoration needs 3 clinical appointments. The first appointment will be used to take an impression of the implant (about 1 hour). The impression is needed to fabricate a cast that will be used to fabricate the implant crown. In the second appointment (about 1 hour), the implant crown will be fitted on the im

Implants will be surgically inserted as per routine surgical procedure. After the integration of the implant (3 months after surgery), the implant will be restored with a crown. Any implant restoration needs 3 clinical appointments. The first appointment will be used to take an impression of the implant (about 1 hour). The impression is needed to fabricate a cast that will be used to fabricate the implant crown. In the second appointment (about 1 hour), the implant crown will be fitted on the implant. A third appointment (about 30 minutes) is needed to review the implant, and normally scheduled within 2-4 weeks after fitting of the implant restoration. Traditionally, implant crowns are fabricated from porcelain-fused to metal. Recently, full contour (monolithic) zirconia is proposed for implant restoration and believed to be durable and aesthetic. The crown can be designed and fabricated to fit directly on the implant, or it can be designed and fabricated to fit on an intermediate component (abutment). The abutment has been suggested to reduce soft tissue manipulation. Therefore, implant full contour (monolithic) zirconia crowns for 2 different designs will be evaluated: 1. Nobel FCZ- protocol: Full contoured zirconia crown on implant 2. Nobel on-1-abutment protocol: Full contoured zirconia crown on intermediate abutment All restorative steps will b e completed under supervision of prosthodontics dental specialists who are familiar with all the applied restorations of the study. To standardise the treatment, the involved clinicians will be calibrated and will follow a data collection form to ensure consistent data gathering for each step of treatment.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Single implant Minimum of 20 functional teeth

Exclusion criteria

Requirement for major or block grafting Head or neck radiation in previous 12 months Metabolic bone disease Severe parafunction Uncontrolled diabetes Smoker Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026