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Trial registered on ANZCTR


Registration number
ACTRN12605000653662
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
18/10/2005
Date last updated
22/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maxillary Three-Implant Overdentures: An Alternative Prosthodontic Treatment Concept with Opposing Mandibular Two-Implant Overdentures.
Scientific title
Complete Tooth Loss:A Randomized Controlled Clincial Trial with Maxillary Three-Implant Overdentures Opposing Mandibular Two-Implant Overdentures.
Secondary ID [1] 286784 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total tooth loss - edentulism 786 0
Condition category
Condition code
Oral and Gastrointestinal 861 861 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 upper jaw and implant overdentures, when opposing lower jaw 2-implant overdentures.
Intervention code [1] 557 0
Treatment: Devices
Intervention code [2] 291939 0
Treatment: Surgery
Comparator / control treatment
Conventional complete maxillary dentures opposing mandibular 2-implant overdentures
Control group
Active

Outcomes
Primary outcome [1] 1104 0
To determine implant success of maxillary three-implant overdentures using splinted and unsplinted prosthodontic designs on narrow diameter roughened surface implants (with a one-stage surgical procedure and a 12-week healing period), when opposing mandibular two-implant overdentures.
Timepoint [1] 1104 0
52 weeks post procedure and 10 years post procedure
Secondary outcome [1] 2043 0
To determine prosthodontic success of maxillary three-implant overdentures using splinted and unsplinted prosthodontic designs on narrow diameter roughened surface implants (with a one-stage surgical procedure and a 12-week healing period), when opposing mandibular two-implant overdentures.
Timepoint [1] 2043 0
10 years post procedure

Eligibility
Key inclusion criteria
An edentulous maxilla, and had been successfully wearing their mandibular two-implant overdenture for at least three years.
Minimum age
55 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with Lekholm & Zarb classification16 Type E maxillae (determined radiologically), a history of smoking, a systemic disease likely to compromise implant surgery, previously bone-grafted jaws, or a history of bruxism.

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
Parallel
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] 217 0
New Zealand
State/province [1] 217 0

Funding & Sponsors
Funding source category [1] 947 0
Commercial sector/Industry
Name [1] 947 0
NobelBiocare
Address [1] 947 0
4/7 Eden Park Drive, Sydney NSW 2113, Australia
Country [1] 947 0
Australia
Funding source category [2] 948 0
Commercial sector/Industry
Name [2] 948 0
Southern Implants
Address [2] 948 0
1 Albert Rd, Pretoria, 0062, South Africa
PO Box 605, Irene, 0062, South Africa
Country [2] 948 0
South Africa
Primary sponsor type
Commercial sector/Industry
Name
NobelBiocare Pty Ltd Australia,
Address
4/7 Eden Park Drive, Sydney NSW 2113, Australia
Country
Australia
Secondary sponsor category [1] 815 0
Commercial sector/Industry
Name [1] 815 0
Southern Implants, South Africa
Address [1] 815 0
1 Albert Rd, Pretoria, 0062, South Africa
PO Box 605, Irene, 0062, South Africa
Country [1] 815 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2246 0
New Zealand - Lower South Island Ethics Committee
Ethics committee address [1] 2246 0
Ethics committee country [1] 2246 0
New Zealand
Date submitted for ethics approval [1] 2246 0
Approval date [1] 2246 0
01/10/2001
Ethics approval number [1] 2246 0

Summary
Brief summary
To determine the implant success and prosthetic maintenance of 3 upper jaw implants supporting an overdenture in patients with a lower jaw 2-implant overdenture over a 10-year period.

Trial website
Trial related presentations / publications
Al-Zubeidi M., Alsabeeha N, Thomson WM, Payne AGT. (2012) Patient outcomes with maxillary 3-implant overdentures opposing mandibular 2-implant overdentures. Clin Implant Dent Relat Res 2012;14,(suppl)1:e11-19.

Ma S, Tawse-Smith A, De Silva RK, Atieh MA, Alsabeeha NHM, Payne AGT. Maxillary 3-implant overdentures opposing mandibular 2-implant overdentures: 10-year surgical outcomes of a randomized controlled trial. Clin Implant Dent Relat Res 2015 doi: 10.1111/cid.12325.

Ma S, Waddell JN, Atieh MA, Alsabeeha NHM, Payne AGT. Maxillary 3-implant overdentures opposing mandibular 2-implant overdentures: 10-year prosthodontic outcomes of a randomized controlled trial. Int J Prosthodontics- submitted for publication
Public notes

Contacts
Principal investigator
Name 35405 0
Dr Alan GT Payne
Address 35405 0
Gentle Dental Co - Gus Cameron
17 Rust Avenue
Whangarei
0110
Northland
Country 35405 0
New Zealand
Phone 35405 0
+6494300046
Fax 35405 0
+6494302807
Email 35405 0
payne@actrix.gen.nz
Contact person for public queries
Name 9746 0
Dr Sunyoung Ma
Address 9746 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 9746 0
New Zealand
Phone 9746 0
+ 64 3 4797044
Fax 9746 0
+64 3 4795079
Email 9746 0
sunyoung.ma@otago.ac.nz
Contact person for scientific queries
Name 674 0
Dr Dr Alan GT Payne
Address 674 0
Gentle Dental Co - Gus Cameron
17 Rust Avenue
Whangarei
0110
Northland
Country 674 0
New Zealand
Phone 674 0
+64 9 4300046
Fax 674 0
+64 3 4795079
Email 674 0
payne@actrix.gen.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