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Trial registered on ANZCTR


Registration number
ACTRN12605000654651
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
18/10/2005
Date last updated
18/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Different loading strategies for mandibular 2-implant overdentures using different systems:A randomized controlled clincial trial
Scientific title
A Randomized Controlled Clincial Trial on Different Loading Strategies using 2-implant Overdentures to Resolve Complete Tooth Loss in the Mandible.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total tooth loss - edentulism 787 0
Condition category
Condition code
Oral and Gastrointestinal 862 862 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
Placement of oral implants in the lower jaw to support implant overdentures.
Intervention code [1] 558 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1105 0
Determine that there are no adverse consequences for smooth machined (turned) titanium surface implants being loaded with mandibular overdentures as early as 2 weeks.
Timepoint [1] 1105 0
Primary outcome [2] 1106 0
Determine that there are no adverse consequences for roughened titanium surface implants being loaded with mandibular overdentures as early as 2 weeks.
Timepoint [2] 1106 0
Secondary outcome [1] 2044 0
The determine the prosthodontic maintennance and success for mandibular overdentures supported by either smooth machined (turned) titanium or roughened titanium surface implants being loaded.
Timepoint [1] 2044 0
As early as 2 weeks.

Eligibility
Key inclusion criteria
Edentulous patients with a history of difficulties with their complete dentures and at least 13-15 mm of residual anterior mandibular bone were selected using standard inclusion and exclusion criteria.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Standard exclusion criteria.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin Toss and Blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 218 0
New Zealand
State/province [1] 218 0

Funding & Sponsors
Funding source category [1] 949 0
Commercial sector/Industry
Name [1] 949 0
NobelBiocare
Address [1] 949 0
Country [1] 949 0
Australia
Funding source category [2] 950 0
Commercial sector/Industry
Name [2] 950 0
Southern Implants
Address [2] 950 0
Country [2] 950 0
South Africa
Funding source category [3] 951 0
Charities/Societies/Foundations
Name [3] 951 0
ITI Research Foundation
Address [3] 951 0
Country [3] 951 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
NobelBiocare, Australia ; Southern Implants South Africa; ITI Research Foundation, Switzerland
Address
Country
Secondary sponsor category [1] 817 0
Commercial sector/Industry
Name [1] 817 0
NobelBiocare, Australia
Address [1] 817 0
Country [1] 817 0
Secondary sponsor category [2] 818 0
Commercial sector/Industry
Name [2] 818 0
Southern Implants South Africa
Address [2] 818 0
Country [2] 818 0
Secondary sponsor category [3] 819 0
Commercial sector/Industry
Name [3] 819 0
ITI Research Foundation Switzerland
Address [3] 819 0
Country [3] 819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2247 0
New Zealand - Lower South Island Ethics Committee
Ethics committee address [1] 2247 0
Ethics committee country [1] 2247 0
New Zealand
Date submitted for ethics approval [1] 2247 0
Approval date [1] 2247 0
Ethics approval number [1] 2247 0

Summary
Brief summary
Early loading with mandibular overdentures at 2 or 6 weeks after implant placement is being evaluated to see if it is an effective treatment modality for edentulous patients to improve their qaulity of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36097 0
Address 36097 0
Country 36097 0
Phone 36097 0
Fax 36097 0
Email 36097 0
Contact person for public queries
Name 9747 0
Dr Alan Payne
Address 9747 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 9747 0
New Zealand
Phone 9747 0
+64 3 4797119
Fax 9747 0
+64 3 4795079
Email 9747 0
alan.payne@dent.otago.ac.nz
Contact person for scientific queries
Name 675 0
Mr Neil Waddell
Address 675 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 675 0
New Zealand
Phone 675 0
+64 3 4797117
Fax 675 0
+64 3 4795079
Email 675 0
neil.waddell@dent.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary