ANZCTR - Registration

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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

10/12/2020

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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

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]

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]

During the time of restoration fitting. Occlusal and proximal contacts evaluation and adjustments are integral part of fitting implant restorations

Secondary outcome [2]

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]

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]

Restoration aesthetics will be rated as acceptable on not acceptable by patient.

Timepoint [3]

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]

Restoration aesthetics will be rated as acceptable on not acceptable by clinician.

Timepoint [4]

Secondary outcome [5]

Patient satisfaction of the treatment will be rated via visual analogue scale.

Timepoint [5]

Secondary outcome [6]

Clinician satisfaction of the treatment will be rated via visual analogue scale.

Timepoint [6]

Eligibility

Key inclusion criteria

Single implant
Minimum of 20 functional teeth

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

30/04/2018

Actual

28/06/2018

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]

University

Name [1]

University of Melbourne

Address [1]

Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3

Country [1]

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]

Commercial sector/Industry

Name [1]

Nobel Biocare

Address [1]

4/7 Eden Park Dr,
Macquarie Park
NSW 2113

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

University of Melbourne
Parkville
Victoria 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/03/2018

Ethics approval number [1]

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

A/Prof Roy Judge

Address

Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3

Country

Australia

Phone

+61 3 93411531

Fax

[email protected]

Contact person for public queries

Name

Jaafar Abduo

Address

Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3

Country

Australia

Phone

+61 3 90358998

Fax

[email protected]

Contact person for scientific queries

Name

Jaafar Abduo

Address

Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 305 3

Country

Australia

Phone

+61 3 90358998

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically