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Trial registered on ANZCTR


Registration number
ACTRN12605000652673
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
18/10/2005
Date last updated
14/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multicentre prospective evaluation of mandibular bilateral distal extension removable partial dentures, supported by ITI dental implants.
Scientific title
A Randomized Controlled Clinical Trial using Mandibular Bilateral Distal Extension Removable Implant Partial Dentures to Resolve Partial Tooth Loss.
Secondary ID [1] 195 0
International Team for Implantology Research Foundation, Switzerland
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial edentulism 785 0
Condition category
Condition code
Oral and Gastrointestinal 860 860 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
Intervention group receives the placement of 2 oral implants to support the removal partial dentures in the mandible.
Intervention code [1] 548 0
Treatment: Devices
Comparator / control treatment
Control group receives conventional removable partial denture in the mandible.
Control group
Active

Outcomes
Primary outcome [1] 1103 0
To prospectively evaluate in a randomized controlled clinical trial the clinical success of single, bilaterally placed ITI oral implants supporting mandibular bilateral distal extension RPD's over a 5-year period.
Timepoint [1] 1103 0
Evaluated annually and up to 5 years.
Secondary outcome [1] 2038 0
1. To evaluate the effect on the development of the combination syndrome (anterior hyperfunction syndrome) by the placement of distal implants on the bilateral edentulous areas in the mandible in participants with RPD's.
Timepoint [1] 2038 0
Annually and up to 5 years
Secondary outcome [2] 2039 0
2. To prospectively compare the prosthodontic maintenance procedures of conventional mandibular bilateral distal extension RPD's and implant-supported mandibular bilateral distal extension RPD's during a 5-year period.
Timepoint [2] 2039 0
Annually and up to 5 years
Secondary outcome [3] 2040 0
3.To evaluate the professional time required for fabrication and prosthodontic maintenance of conventional mandibular bilateral distal extensions RPD's, as compared to implant-supported mandibular bilateral distal extension RPD's.
Timepoint [3] 2040 0
Annually and up to 5 years
Secondary outcome [4] 2041 0
4.To prospectively compare periodontal parameters of conventional mandibular bilateral distal extension RPD's as opposed to implant-supported mandibular bilateral distal extension RPD's.
Timepoint [4] 2041 0
Annually and up to 5 years
Secondary outcome [5] 2042 0
5.To compare the patient satisfaction levels (within-subject comparison) of conventional mandibular bilateral distal extension RPD's (Kennedy Class I) as opposed to implant-supported RPD's either supported only implants with healing caps or also retained by the implants with retentive anchors.
Timepoint [5] 2042 0
Annually and up to 5 years

Eligibility
Key inclusion criteria
1. be categorised as being in one of three categories of patient edentulism (Class I, II or III) as defined by the American College of Prosthodontists (McGarry et al. 2002).2. an edentulous maxilla, and a Kennedy Classification I mandibular arch with healthy periodontal tissues around the natural teeth. They should be having difficulty wearing their existing mandibular partial denture opposing the maxillary complete denture; exacerbated with on-going residual ridge resorption. 3. With sufficient bone volume in the posterior mandible to receive two implants of at least 8-10mm in length and 4.1mm in diameter; 4. having suitable bone quality as assessed radiographically (Lekholm & Zarb 1985). 5. have sufficient bone volume to fulfil one of the Cawood & Howell (1988) residual ridge classifications, except Class VI.
Minimum age
30 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients with a Class IV category of American College of Prosthodontists classification of partial edentulism (McGarry et al. 2002).2. physical and mental disabilities which interfere with the maintenance of implants or removal of the RPD's.

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 1 / Phase 2
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] 214 0
New Zealand
State/province [1] 214 0
Country [2] 6877 0
Colombia
State/province [2] 6877 0
Country [3] 6878 0
Netherlands
State/province [3] 6878 0

Funding & Sponsors
Funding source category [1] 946 0
Charities/Societies/Foundations
Name [1] 946 0
International Team for Implantology Research Foundation
Address [1] 946 0
Peter Merian-Strasse 88
4052
Basel
Country [1] 946 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
International Team for Implantology Research Foundation, Switzerland
Address
Peter Merian-Strasse 88
4052
Basel
Country
Switzerland
Secondary sponsor category [1] 814 0
Charities/Societies/Foundations
Name [1] 814 0
International Team for Implantology Research Foundation, Switzerland
Address [1] 814 0
Peter Merian-Strasse 88
4052
Basel
Country [1] 814 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2242 0
Lower South Island Ethics Committee of New Zealand
Ethics committee address [1] 2242 0
Ethics committee country [1] 2242 0
New Zealand
Date submitted for ethics approval [1] 2242 0
Approval date [1] 2242 0
11/06/2004
Ethics approval number [1] 2242 0
Ethics committee name [2] 2243 0
Netherlands
Ethics committee address [2] 2243 0
Ethics committee country [2] 2243 0
Netherlands
Date submitted for ethics approval [2] 2243 0
Approval date [2] 2243 0
Ethics approval number [2] 2243 0
Ethics committee name [3] 2244 0
Colombia
Ethics committee address [3] 2244 0
Ethics committee country [3] 2244 0
Colombia
Date submitted for ethics approval [3] 2244 0
Approval date [3] 2244 0
Ethics approval number [3] 2244 0
Ethics committee name [4] 2245 0
South America
Ethics committee address [4] 2245 0
Ethics committee country [4] 2245 0
Date submitted for ethics approval [4] 2245 0
Approval date [4] 2245 0
Ethics approval number [4] 2245 0

Summary
Brief summary
A multicentre study in New Zealand, Colombia and the Netherlands to evaluate the outcomes of removable partial dentures (plates) supported by oral implants
Trial website
Trial related presentations / publications
Wismeijer D, Tawse-Smith A, Payne AGT. (2013) Multicentre prospective evaluation of implant–assisted mandibular bilateral distal extension removable partial dentures: Patient satisfaction. Clinical Oral Implants Research 24 : 20-27.

Payne AGT, Wismeijer D, Tawse-Smith A, Ma S. (2015) Multicentre prospective evaluation of implant–assisted mandibular removable partial dentures: Surgical and prosthodontic outcomes. Clinical Oral Implants Research. Submitted for publication.

Public notes

Contacts
Principal investigator
Name 35534 0
Dr Alan GT Payne
Address 35534 0
Private practice
Gentle Dental Co - Gus Cameron
17 Rust Avenue
Whangarei
0110
Northland
Country 35534 0
New Zealand
Phone 35534 0
+6494300046
Fax 35534 0
+6494302807
Email 35534 0
payne@actrix.gen.nz
Contact person for public queries
Name 9737 0
Dr Sunyoung Ma
Address 9737 0
Oral Implantology Area of Research Strength
School of Dentistry
University of Otago
280 Great King St
Dunedin 9003
Country 9737 0
New Zealand
Phone 9737 0
+64 3 4797044
Fax 9737 0
+64 3 4795079
Email 9737 0
sunyoung.ma@otago.ac.nz
Contact person for scientific queries
Name 665 0
Dr Alan GT Payne
Address 665 0
Gentle Dental Co - Gus Cameron
17 Rust Avenue
Whangarei
0110
Northland
Country 665 0
New Zealand
Phone 665 0
+64 9 4300046
Fax 665 0
+64 9 4302807
Email 665 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