RecruitingACTRN12618000614291

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

Sponsor

University of Melbourne

Enrollment

50 participants

Start Date

Jun 28, 2018

Study Type

Interventional

Conditions

Restoration of single-tooth dental implants

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two different design approaches for full-contour zirconia crowns — metal-free ceramic tooth caps — placed on dental implants. Zirconia is a strong, tooth-coloured material that is increasingly popular as an alternative to traditional metal-backed ceramic crowns, which require more complex manufacturing. However, long-term clinical data on the best design for zirconia implant crowns is still limited. Participants with single dental implants will receive either one design type or the other and be followed up over several years to assess fracture rate, fit, aesthetics, and overall clinical performance. The results will help dentists make better-informed decisions about which crown design to recommend. You may be eligible if you need a crown on a single dental implant and have at least 20 functional teeth. People who are pregnant, smoke, have uncontrolled diabetes, metabolic bone disease, have had head or neck radiation in the past year, or have severe teeth-grinding habits are not eligible.

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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 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.

Locations(1)

VIC, Australia

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