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Trial registered on ANZCTR


Registration number
ACTRN12605000655640
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
A Randomised, Controlled, Clinical Trial of Conventional and Immediately Loaded Tapered Implants, With Screw-Retained Crowns.
Scientific title
A Randomised, Controlled, Clinical Trial of Conventional and Immediately Loaded Tapered Implants, With Screw-Retained Crowns to Resolve Single Tooth Loss.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial tooth loss - partial edentulism 788 0
Condition category
Condition code
Oral and Gastrointestinal 863 863 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 single oral implants in the upper jaw to support single implant crowns for 5 years.
Intervention code [1] 569 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1107 0
To compare surgical outcomes of conventional and immediately loaded, single, tapered implants restored with screw-retained crowns in the anterior maxilla.
Timepoint [1] 1107 0
Annually for up to 5 years.
Secondary outcome [1] 2045 0
To compare prosthodontic and patient outcomes of conventional and immediately loaded, single, tapered implants restored with screw-retained crowns in the anterior maxilla.
Timepoint [1] 2045 0
Annually for up to 5 years.

Eligibility
Key inclusion criteria
1) Able to understand and sign the informed consent form prior to starting of the study. 2) Able and willing to comply with all study requirements. 3) Adequate oral hygiene. 4) Adequate bone volume to accommodate the implant (implant lengths of 10-15mm; diameter of 2.5-4.0mm). 5) Good bone quality (class I-III) at the implant recipient site by radiographic assessment (Lekholm & Zarb 1985). 6) Recipient site for single implant in the anterior maxilla (Zone 1 or anterior portion of Zone 2). Patient may have one or two sites. Each site must have teeth mesial and distal to it. 7) Intention to be a long-term (minimum 5 years) resident of the Otago region, New Zealand. Able to participate in the trial and attend annual recalls.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Heavy smoking or tobacco chewing2) History of alcoholism or drug abuse3) Severe bruxism or clenching habits4) Physical and/or mental disabilities, which will interfere with the maintenance of the implants5) Previous history of failed implant6) History of radiation treatment to the head and neck7) Undergoing chemotherapy8) Long-term therapy with steroids, immunosuppressants or biphosphates9) Insulin dependent and uncontrolled adult onset diabetic patients10) Chronic renal or liver disease11) Systemic and local bone disorders and pathology12) Serious cardiac and pulmonary disorders13) Haematological disorders14) High risk of developing bacterial endocarditis15) Immuno-compromised patient including HIV-positive16) Untreated periodontitis.

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 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 outside Australia
Country [1] 219 0
New Zealand
State/province [1] 219 0

Funding & Sponsors
Funding source category [1] 952 0
Commercial sector/Industry
Name [1] 952 0
Southern Implants
Address [1] 952 0
Country [1] 952 0
South Africa
Primary sponsor type
Commercial sector/Industry
Name
Southern Implants, South Africa
Address
Country
South Africa
Secondary sponsor category [1] 820 0
Commercial sector/Industry
Name [1] 820 0
Southern Implants South Africa
Address [1] 820 0
Country [1] 820 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2248 0
New Zealand - Lower South Island Ethics Committee
Ethics committee address [1] 2248 0
Ethics committee country [1] 2248 0
New Zealand
Date submitted for ethics approval [1] 2248 0
Approval date [1] 2248 0
Ethics approval number [1] 2248 0

Summary
Brief summary
To compare surgical, prosthodontic, and patient outcomes of conventional and immediately loaded, single, tapered implants restored with screw-retained crowns in the anterior maxilla.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35855 0
Address 35855 0
Country 35855 0
Phone 35855 0
Fax 35855 0
Email 35855 0
Contact person for public queries
Name 9758 0
Dr Alan Payne
Address 9758 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 9758 0
New Zealand
Phone 9758 0
+64 3 4797119
Fax 9758 0
+64 3 4795079
Email 9758 0
alan.payne @dent.otago.ac.nz
Contact person for scientific queries
Name 686 0
Dr Warwick Duncan
Address 686 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 686 0
New Zealand
Phone 686 0
+64 3 4797110
Fax 686 0
+64 3 4795079
Email 686 0
warwick.duncan@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