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Trial registered on ANZCTR


Registration number
ACTRN12618000614291
Ethics application status
Approved
Date submitted
5/04/2018
Date registered
20/04/2018
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the long-term clinical outcome of two designs of high strength ceramic (zirconia) crowns on dental implants
Scientific title
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
Secondary ID [1] 294509 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restoration of single-tooth dental implants
307280 0
Condition category
Condition code
Oral and Gastrointestinal 306399 306399 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300805 0
Treatment: Devices
Comparator / control treatment
Comparison will made against traditional implant crowns (porcelain-fused to metal). The data will be obtained from recent literature and published clinical trials from Melbourne Dental Schools. Two clinical trials were published by the involved supervisors in 2017 on traditional implant crowns
Control group
Historical

Outcomes
Primary outcome [1] 305413 0
Implant restoration survival in the form of incidence of complications (biological and mechanical) in percentages, as assessed by researcher clinician. The complications can be peri-implant soft tissue inflammation, discoloration of peri-implant soft tissue, loosening of restoration screw, chipping of ceramic restoration and restoration fracture. These complications are composite primary outcome and can be detected by visual inspection of the soft tissue and the restoration, routine radiographic evaluation and palpation of the restoration.
Timepoint [1] 305413 0
Baseline: immediately after restoring the implant (at the same appointment)
1st follow-up (primary timepoint): preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)
Secondary outcome [1] 345112 0
Clinical accuracy of each system in the form of occlusal and proximal contacts at the time of restoration fitting on the implant. The clinical accuracy is composite measurement of occlusal and proximal contacts:
- Occlusal contacts will be evaluated evaluated qualitatively and rated as: ideal, minor adjustment (chairside). major adjustment (return to manufacturer) or misfitting (remake)
- Proximal contacts against adjacent teeth will be evaluated qualitatively and rated as: ideal, tight (minor adjustment, open (major adjustment) or misfitting (remake)
Timepoint [1] 345112 0
During the time of restoration fitting. Occlusal and proximal contacts evaluation and adjustments are integral part of fitting implant restorations
Secondary outcome [2] 345566 0
Soft tissue response will be evaluated by composite measurements of the probing pocket depth (mm), bleeding on probing (present or absent) and metallic discoloration (present or absent).
The probing depth and bleeding on probing will be assessed by periodontal probe. The metallic discoloration will be assessed by visual inspection of the peri-implant soft tissue.
Timepoint [2] 345566 0
1st follow-up: preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)
Secondary outcome [3] 345835 0
Restoration aesthetics will be rated as acceptable on not acceptable by patient.
Timepoint [3] 345835 0
Baseline: immediately after restoring the implant (at the same appointment)
1st follow-up: preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)
Secondary outcome [4] 345836 0
Restoration aesthetics will be rated as acceptable on not acceptable by clinician.
Timepoint [4] 345836 0
Baseline: immediately after restoring the implant (at the same appointment)
1st follow-up: preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)
Secondary outcome [5] 345837 0
Patient satisfaction of the treatment will be rated via visual analogue scale.
Timepoint [5] 345837 0
Baseline: immediately after restoring the implant (at the same appointment)
1st follow-up: preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)
Secondary outcome [6] 345838 0
Clinician satisfaction of the treatment will be rated via visual analogue scale.
Timepoint [6] 345838 0
Baseline: immediately after restoring the implant (at the same appointment)
1st follow-up: preferably 2 weeks post-restoration of the implant, but can extend to up to 4 weeks post-insertion (to accommodate patient's availability)
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 year after implant restoration
3rd recall visit: 3rd year after implant restoration
4th recall visit: 4th year after implant restoration
5th recall visit: 5th year after implant restoration (endpoint of the study)

Eligibility
Key inclusion criteria
Single implant
Minimum of 20 functional teeth
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following informed consent and fulfillment of inclusion/exclusion criteria, patients will be sequentially allocated a treatment ID code. Once a treatment ID has been allocated, the treating clinician will be issued a sealed envelope marked with that treatment ID containing a centrally generated treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is via computer-generated schedule using blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299135 0
University
Name [1] 299135 0
University of Melbourne
Address [1] 299135 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3
Country [1] 299135 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3
Country
Australia
Secondary sponsor category [1] 298394 0
Commercial sector/Industry
Name [1] 298394 0
Nobel Biocare
Address [1] 298394 0
4/7 Eden Park Dr,
Macquarie Park
NSW 2113
Country [1] 298394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300066 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 300066 0
University of Melbourne
Parkville
Victoria 3010
Ethics committee country [1] 300066 0
Australia
Date submitted for ethics approval [1] 300066 0
Approval date [1] 300066 0
13/03/2018
Ethics approval number [1] 300066 0
1750544.1

Summary
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.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 82450 0
A/Prof Roy Judge
Address 82450 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3
Country 82450 0
Australia
Phone 82450 0
+61 3 93411531
Fax 82450 0
Email 82450 0
roybj@unimelb.edu.au
Contact person for public queries
Name 82451 0
Dr Jaafar Abduo
Address 82451 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3
Country 82451 0
Australia
Phone 82451 0
+61 3 90358998
Fax 82451 0
Email 82451 0
jaafar.abduo@unimelb.edu.au
Contact person for scientific queries
Name 82452 0
Dr Jaafar Abduo
Address 82452 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3
Country 82452 0
Australia
Phone 82452 0
+61 3 90358998
Fax 82452 0
Email 82452 0
jaafar.abduo@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This aspect will be consulted with the Human Ethics Committee of Melbourne University
What supporting documents are/will be available?
No other documents available
Summary results
No Results