Trial Review

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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.
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.
Secondary ID [1] 262311 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 268017 0
Condition category
Condition code
Oral and Gastrointestinal 268146 268146 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
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).
Intervention code [1] 266701 0
Treatment: Devices
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).
Control group
Active

Outcomes
Primary outcome [1] 266894 0
Ease of use of system by clinician assessed by questionnaire (designed by the researchers and tested for clarity) at the time of treatment.
Timepoint [1] 266894 0
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.
Primary outcome [2] 266895 0
Maintenance required and clinical outcomes assessed by a questionnaire (designed by the researchers and tested for clarity) at review appointments.
Timepoint [2] 266895 0
1 year review
2 year review
Secondary outcome [1] 276579 0
Ease of use of system by laboratory technician assessed by questionnaire (designed by the researchers and tested for clarity) during fabrication of restoration.
Timepoint [1] 276579 0
Restoration construction

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?
Yes
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
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267184 0
University
Name [1] 267184 0
University Of Melbourne
Country [1] 267184 0
Australia
Primary sponsor type
University
Name
University Of Melbourne
Address
Parkville, Victoria 3010
Country
Australia
Secondary sponsor category [1] 266257 0
Commercial sector/Industry
Name [1] 266257 0
Biomet 3i
Address [1] 266257 0
6-8 Byfield Street
North Ryde NSW 2113
Country [1] 266257 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269179 0
University of Melbourne
Ethics committee address [1] 269179 0
Ethics committee country [1] 269179 0
Australia
Date submitted for ethics approval [1] 269179 0
Approval date [1] 269179 0
21/05/2011
Ethics approval number [1] 269179 0
1034995
Ethics committee name [2] 269260 0
Human Research Ethics Committee, Dental Health Services Victoria
Ethics committee address [2] 269260 0
Ethics committee country [2] 269260 0
Australia
Date submitted for ethics approval [2] 269260 0
Approval date [2] 269260 0
16/05/2011
Ethics approval number [2] 269260 0
237

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32696 0
Address 32696 0
Country 32696 0
Phone 32696 0
Fax 32696 0
Email 32696 0
Contact person for public queries
Name 15943 0
Dr Denise Bailey
Address 15943 0
Melbourne Dental School
Level 6, 720 Swanston Street
Parkville
Victoria 3010
Country 15943 0
Australia
Phone 15943 0
+61 3 9341 1559
Fax 15943 0
Email 15943 0
dlbailey@unimelb.edu.au
Contact person for scientific queries
Name 6871 0
Dr Denise Bailey
Address 6871 0
Melbourne Dental School
Level 6, 720 Swanston Street
Parkville
Victoria 3010
Country 6871 0
Australia
Phone 6871 0
+61 3 9341 1559
Fax 6871 0
Email 6871 0
dlbailey@unimelb.edu.au

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.