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Trial registered on ANZCTR
Registration number
ACTRN12611000578909
Ethics application status
Approved
Date submitted
3/06/2011
Date registered
6/06/2011
Date last updated
20/06/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
A comparative study of the ease-of use of the Encode technique versus conventional dental implant impression systems.
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Scientific title
A comparative study of the ease-of-use of the Encode technique versus conventional implant impression systems for simple, single-tooth dental implant cases.
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Secondary ID [1]
262311
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Restoration of single-tooth dental implants
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Condition category
Condition code
Oral and Gastrointestinal
268146
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Encode system will be used at the time of implant restoration. This system does not involve the removal of the healing abutment or placement of an impression coping. An impression of the healing abutment is taken which is then scanned at the laboratory. Patients attend for 5 standard treatment visits (over a 6 month period) plus 2 further review appointments at yearly intervals (standard procedure).
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Intervention code [1]
266701
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Treatment: Devices
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Comparator / control treatment
The conventional implant restoration involves additional procedures including removal of the healing abutment, placement of an impression coping and then replacement of the healing abutment. The restoration is then fabricated using conventional techniques in the laboratory. Patients attend for 5 standard treatment visits (over a 6 month period) plus 2 further review appointments at yearly intervals (standard procedure).
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Control group
Active
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Outcomes
Primary outcome [1]
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Ease of use of system by clinician assessed by questionnaire (designed by the researchers and tested for clarity) at the time of treatment.
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Assessment method [1]
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Timepoint [1]
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Surgery
Restoration fitting
1 year review
2 year review
Note: Surgical placement of the implant is not part of the study and restorations will be fabricated for implants placed as part of normal procedure. However, it is possible that surgical factors may have an impact on the ease-of-use of either restorative system, therefore the practitioner placing implants for subjects who have consented to be part of the study will collect relevant surgical information via questionnaire.
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Primary outcome [2]
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Maintenance required and clinical outcomes assessed by a questionnaire (designed by the researchers and tested for clarity) at review appointments.
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Assessment method [2]
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Timepoint [2]
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1 year review
2 year review
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Secondary outcome [1]
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Ease of use of system by laboratory technician assessed by questionnaire (designed by the researchers and tested for clarity) during fabrication of restoration.
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Assessment method [1]
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Timepoint [1]
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Restoration construction
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Eligibility
Key inclusion criteria
Single implant
Minimum of 20 functional teeth
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is via computer-generated schedule using blocks.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Due to the use of devices which are markedly different in appearance and clinical technique, neither the clinician nor patient will be blinded as to the treatment allocated.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University Of Melbourne
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Address [1]
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Parkville, Victoria 3010
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University Of Melbourne
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Address
Parkville, Victoria 3010
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Biomet 3i
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Address [1]
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6-8 Byfield Street
North Ryde NSW 2113
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Melbourne
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Ethics committee address [1]
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Parkville, Victoria 3010
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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21/05/2011
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Ethics approval number [1]
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1034995
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Ethics committee name [2]
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Human Research Ethics Committee, Dental Health Services Victoria
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Ethics committee address [2]
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Corporate Office, DHSV, 720 Swanston Street, Carlton, VIC 3053
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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16/05/2011
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Ethics approval number [2]
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237
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Summary
Brief summary
The purpose of this study is to find out if the Encode implant restoration system allows for faster and simpler treatment compared to traditional implant restoration systems. the Encode system uses computerised scanning of the dental impression and does not require the use of impression copings.
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Trial website
na
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Trial related presentations / publications
na
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Denise Bailey
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Address
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Melbourne Dental School
Level 6, 720 Swanston Street
Parkville
Victoria 3010
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Country
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Australia
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Phone
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+61 3 9341 1559
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Denise Bailey
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Address
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Melbourne Dental School
Level 6, 720 Swanston Street
Parkville
Victoria 3010
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Country
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Australia
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Phone
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+61 3 9341 1559
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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.
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