Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000139471
Ethics application status
Approved
Date submitted
22/06/2006
Date registered
22/02/2007
Date last updated
22/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate loading of Branemark implants with fixed full-arch prosthesis: ALL-ON-FOUR CONCEPT
Scientific title
Immediate loading of Branemark implants with fixed full-arch prosthesis in edentulous patients: Prospective evaluation of the success rate of the ALL-ON-FOUR implant rehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous patients 1633 0
Condition category
Condition code
Oral and Gastrointestinal 1740 1740 0 0
Other surgery
Physical Medicine / Rehabilitation 1741 1741 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The latest technique for placing dental implants on edentulous patients (no teeth) is called All-on-Four, and this involves placing a full arch restoration fixed onto four implants in each jaw at the same day. The prospective study will involve the selection of 20 randomly selected patients (10 male and 10 female patients) who are edentulous in both maxilla and mandible. The patients will be followed for 3 years.
Intervention code [1] 1147 0
Rehabilitation
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2426 0
Prospectively evaluate the success rate of ‘All-on-Four’ implant rehabilitation. The patients will be put on a recall program which involves:
Clinical examination and Resonance frequency analysis once a month during the first 6 months.
Timepoint [1] 2426 0
The patients will be put on a recall program during the first 6 months as follows: every week during the first month and then every month until the 6th month. Thereafter they will be evaluated at 12 month post loading and then annually for three years.

Clinical examination and Resonance frequency analysis once a month during the first 6 months.
Primary outcome [2] 2427 0
Prospectively evaluate the success rate of ‘All-on-Four’ implant rehabilitation. The patients will be put on a recall program which involves:
Clinical examination and Resonance frequency analysis, and Radiographic evaluation.
Timepoint [2] 2427 0
The patients will be put on a recall program during the first 6 months as follows: every week during the first month and then every month until the 6th month. Thereafter they will be evaluated at 12 month post loading and then annually for three years.

Clinical examination and Resonance frequency analysis, and Radiographic evaluation evaluated once a year after the first 6 months.
Primary outcome [3] 2428 0
Prospectively evaluate the success rate of ‘All-on-Four’ implant rehabilitation. The patients will be put on a recall program which involves:
Microbiological analysis which will be conducted as follows:
Prior to placing the implants, baseline microbiological samples of the oral cavity will be taken as 1) salivary sample and 2) swab from the area of the edentulous ridge. At each review period and using standard techniques, samples will be taken from:
1. salivary sample
2. swab from the edentulous area under the prosthesis
3. swab from the prosthesis
4. sample from around each of the implants
Timepoint [3] 2428 0
The patients will be put on a recall program during the first 6 months as follows: every week during the first month and then every month until the 6th month. Thereafter they will be evaluated at 12 month post loading and then annually for three years.

Clinical examination and Resonance frequency analysis, and Radiographic evaluation evaluated once a year after the first 6 months.
Secondary outcome [1] 4194 0
Evaluate patients’ satisfaction before and after treatment.
Timepoint [1] 4194 0
The patients will be put on a recall program during the first 6 months as follows: every week during the first month and then every month until the 6th month. Thereafter they will be evaluated at 12 month post loading and then annually for three years.
Secondary outcome [2] 4195 0
Analyse the development of the microbial flora associated with this implant/prosthesis system.
Timepoint [2] 4195 0
Secondary outcome [3] 4196 0
Relate the microbial flora to the health of the implant and/or development of peri-implantitis.
Timepoint [3] 4196 0

Eligibility
Key inclusion criteria
Patients will be included in the study according to the following criteria:1.completely edentulous mandible and maxilla for at least one year2.rehabilitation with oral implants will be considered an elective procedure3.they are physically and medically able to tolerate conventional surgical and restorative procedures4.they agree to give signed informed consent5.they have adequate, good quality bone in both the mandible and maxilla6. all implants can be seated with a torque > 35Ncm and have initial primary stability.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients to be excluded from the study include:1.the presence of pathological lesions, active infection or inflammation in the areas intended for implant placement2.history of a chronic smoking habit3.systemic diseases such as diabetes (all types, regardless of control)4.treatment with therapeutic radiation to the head within the past 12 months5.the need for bone augmentation at the intended implant site6.the presence of a previous unresorbed allograft at the implant site (as detected by radiographs)7.a habit of severe bruxism or clenching.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 356 0
New Zealand
State/province [1] 356 0

Funding & Sponsors
Funding source category [1] 1890 0
Commercial sector/Industry
Name [1] 1890 0
Nobelbiocare
Country [1] 1890 0
Sweden
Primary sponsor type
Commercial sector/Industry
Name
Nobelbiocare, Sweden
Address
Country
Sweden
Secondary sponsor category [1] 1709 0
None
Name [1] 1709 0
NIL
Address [1] 1709 0
Country [1] 1709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3515 0
Lower South Regional Ethics Committee Ministry of Health
Ethics committee address [1] 3515 0
229 Moray Place Dunedin
Ethics committee country [1] 3515 0
New Zealand
Date submitted for ethics approval [1] 3515 0
Approval date [1] 3515 0
05/05/2006
Ethics approval number [1] 3515 0
LRS/05/12/046

Summary
Brief summary
Recently, an “All-on-4” (NobelBiocare) concept has been advocated as a possible solution for complete edentulous rehabilitation involving placement of full fixed acrylic bridgework immediately loaded on four implants located in the anterior mandible or maxilla of edentulous patients. This treatment modality has expanded the indication for dental implant therapy to include cases that otherwise could be contraindicated for implant-supported fixed prosthesis. Furthermore, the treatment concept is a very cost-effective rehabilitation for completely edentulous patients which make dental implant therapy affordable for a broader range of these patients.The aims of this clinical trial are to:
· evaluate the success rate of ‘All-on-Four’ implant rehabilitation
· Develop simplified surgical guides and prosthodontic techniques to allow accurate implant placement and provision of functional full arch rehabilitation immediately after implant placement.
· Evaluate patients’ satisfaction before and after treatment.
· Analyse the development of the microbial flora associated with this implant/prosthesis system
· Relate the microbial flora to the health of the implant
The hypothesis is:
· The ‘All-on-Four’ implant rehabilitation will provide a high degree of patient satisfaction
· The ‘All-on-Four’ implant rehabilitation will show high success values with respect to implant survival, and function and aesthetics of the prosthesis
· Health of tissues surrounding an implant will be associated with a non-pathogenic bacterial flora.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35753 0
Address 35753 0
Country 35753 0
Phone 35753 0
Fax 35753 0
Email 35753 0
Contact person for public queries
Name 10336 0
Dusan Kuzmanovic
Address 10336 0
School of Dentistry
Univeristy of Otago
PO Box 647
Dundein
Country 10336 0
New Zealand
Phone 10336 0
+6434797044
Fax 10336 0
+6434797046
Email 10336 0
dusan.kuzmanovic@dent.otago.ac.nz
Contact person for scientific queries
Name 1264 0
Dusan Kuzmanovic
Address 1264 0
School of Dentistry
Univeristy of Otago
PO Box 647
Dundein
Country 1264 0
New Zealand
Phone 1264 0
+64 3 4797044
Fax 1264 0
+64 3 4797046
Email 1264 0
dusan.kuzmanovic@dent.otago.ac.nz

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