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Trial registered on ANZCTR


Registration number
ACTRN12610000037000
Ethics application status
Approved
Date submitted
15/12/2009
Date registered
13/01/2010
Date last updated
17/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Ceramic implants to support dentures for the edentolous patients: a new metal free approach
Scientific title
Ceramic implants to support dentures for the edentolous patients: a new metal free approach
Secondary ID [1] 1264 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This research is designed to evaluate the surgical and peri-implant prosthodontic outcomes of one-piece titanium and ceramic implant designs supporting overdentures 252282 0
Condition category
Condition code
Oral and Gastrointestinal 256687 256687 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
Test group: ceramic implants will be used

The in-vitro study will utilize numerical modelling and finite element analysis to develop novel designs for ceramic implants and metal-free attachment systems for implant overdentures.

The in-vivo study will involve surgical and prosthodontic rehabilitation of 40 completely edentulous participants with implant overdentures

The surgical procedure for the placement of ceramic/titanium will be according to a standard protocol by one surgeon. The surgeon will access that portion of the jawbone where the ceramic/titanium implant will be placed. Initially the surgeon will need to access the bone that lies in the region where the tooth implant will be placed. To do so, the surgeon will create a few incisions in the patient's gums that outline two separate flaps of gum tissue. The surgeon will then use a hand instrument to push and peel each flap of gum tissue back, so the bone that lies underneath is revealed. The implant drilling and placement process can then be performed. Each patient will receive three implants in the mandible on the first surgical visit and on the second surgical visit he/she will receive four implants for the upper jaw. Each visit will take two hours. Follow-up visit will be of 15 minutes to remove the sutures.
Intervention code [1] 241600 0
Rehabilitation
Comparator / control treatment
In the control group: the implants will be made from titanium
Control group
Active

Outcomes
Primary outcome [1] 253331 0
Surgical outcomes High success rates of cermic/titanium implants will demonstrate high surgical outcomes Outcome measurement: Implant success will be evaluated using a four field table according to Albrektsson and Zarb (1993 & 1998) Marginal bone loss measures by standardized radiographs (Payne et al., 1999). Implant stability: evaluated by resonance frequency analysis (Meredith, 1998; Sennerby and Meredith, 1998). Modified plaque index (Mombelli et al., 1987; Mombelli and Lang, 1994) Modified sulcus bleeding index (Mombelli et al., 1987; Mombelli and Lang, 1994).
Timepoint [1] 253331 0
Baseline, one year and annually thereafter for 5 years
Primary outcome [2] 253333 0
Prosthetic design that is number and distribution of implants will be evaluated

This research will be conducted using both an in-vitro and in-vivo study. Firstly, the in-vitro research will evaluate and develop novel designs of ceramic implants to support maxillary and mandibular overdentures and their plastic metal-free attachment systems. Secondly, the in-vivo study will be performed to determine the prosthodontic outcome of novel distribution of ceramic and titanium implants supporting maxillary and mandibular overdentures using plastic attachment systems.
In addition, a qualitative research will be conducted to evaluate overall patients' general perception on titanium or ceramic implants supporting overdentures.
In-vitro study:

Numerical modeling and finite element analyses to develop novel designs for ceramic implants and plastic attachment systems for implant overdentures.

Propose an ideal attachment system for ceramic implants in terms of material and design that would require minimal or negligible maintenance possible based on the outcome of these investigations.

Investigate the extent of prosthodontic maintenance and repair as well as the causes of failures of one-piece ceramic implants and their attachment systems for implant overdentures

A semi-structured interview as a qualitative assessment will be conducted to perceive patients' perception on titanium and ceramic implants supporting overdentures. Subsequent to each answer being recorded, the response will be read back to the participant for confirmation and further clarification. This will also enable the assessment of the rationale for the participants' preference for a particular type of an implant material and address their adaptive and maladaptive nature to removable prostheses.
Timepoint [2] 253333 0
Baseline, one year and annually thereafter for 5 years
Primary outcome [3] 253334 0
Baseline, one year and annually thereafter for 5 years
Timepoint [3] 253334 0
At baseline, one year, annually thereafter for 5 years
Secondary outcome [1] 262688 0
Baseline, one year and annually thereafter for 5 years
Timepoint [1] 262688 0
At baseline, one year, annually thereafter for 5 years

Eligibility
Key inclusion criteria
Edentulous participants requesting maxillary and mandibular overdentures with adequate bone volume & quality to accommodate implants, good compliance & commitment to attend follow-up review appointments.
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient with any systemic disorder that precludes implant placement, bruxism or parafunctional habits, history of irradiation to head & neck, drug and/or alcoholic dependence, systemic or local bone pathology, smokers. Patients on intra venous (IV) forms of bisphosphonates

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)
Principal investigators will blindly allocate participants to either of the 2 groups by asking them to pick up one of the sequentially numbered, opaque sealed envelopes containing either of the two interventions.

By this way each participant will have an equal chance of being assigned to one of the two groups.

Randomization process will be based in accordance with items 8-10 of the CONSORT statement 2001-checklist for the randomized controlled clinical trials (Cochrane Collaboration, Manchester, UK).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2339 0
New Zealand
State/province [1] 2339 0

Funding & Sponsors
Funding source category [1] 244079 0
Commercial sector/Industry
Name [1] 244079 0
Southern Implants (Ltd)
Country [1] 244079 0
South Africa
Primary sponsor type
Commercial sector/Industry
Name
Southern Implants (Ltd)
Address
Southern Implants
South Africa
I PO Box 605
Country
South Africa
Secondary sponsor category [1] 251425 0
Government body
Name [1] 251425 0
Department of Health
Address [1] 251425 0
Sir JohnWalsk research Institute,
School of Dentistry,
University of Otago
310 Great King Street
Dunedin
Country [1] 251425 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258174 0
Lower South Ethics Committee.
Ethics committee address [1] 258174 0
Lower South Ethics Committee.
Ministry of Health
229 Moray Palace
PO Box 5849
Dunedin
Ethics committee country [1] 258174 0
New Zealand
Date submitted for ethics approval [1] 258174 0
02/07/2009
Approval date [1] 258174 0
21/07/2009
Ethics approval number [1] 258174 0
LRS/09/06/023

Summary
Brief summary
Background: Titanium implants have been used in the last four decades to replace missing teeth. Alternatives to titanium such as zirconia may offer aesthetic advantages and be more acceptable to patients and clinicians concerned about titanium allergy, but must show equivalent biological acceptability to titanium.
Purpose: The research aimed to investigate soft and hard tissue response to Titanium (Ti) and Zirconia (Zr) implants in edentulous patients.
Materials and Methods: The research included 24 participants (Ti =12, Zr =12) restored with one-piece ball-abutment implants to support overdentures. Participants received four maxillary implants (two in the premolar alveolus, one off-centre in the alveolar mid-line and one wide-diameter implant in the anterior median palate) and three mandibular implants (one in the mid-line and bilateral posterior implants).
Results: Success rates for both Ti and Zr implants were low, 67.9% for all alveolar implants and a survival rate of 50.0% for the palatal implants. Only 11 (52.4%) of 21 palatal implants survived the follow up period. Peri-implant health was equivalent for Ti and Zr implants, and showed no statistically significant changes from loading to the one-year follow-up. Statistically significant differences were noted in radiographic bone level between titanium and zirconia implants (p= 0.02), with Zr showing greater bone loss.
Conclusions: This study has demonstrated higher failure rates of one-piece titanium and one-piece ceramic implants. The use of the one-piece-ceramic or titanium implants presented in this study cannot be recommended
Trial website
Trial related presentations / publications
1. Siddiqi, A, Kieser JA, De Silva, RK, McNaughton A, Zafar S, Duncan WJ. (2013) Histomorphometric comparison of trabecular bone micro-architecture in the median palate and maxillary premolar alveolar sites of edentulous elderly cadavers. Accepted for publication in Journal of Oral and Maxillofacial Surgey.
2. Siddiqi, A, Kieser JA, De Silva, Zafar S, Duncan WJ. Bone-implant contact of Zirconium ceramic implants versus Titanium implants in the jaw and femur of a new ovine animal model. (2013) Submitted for publication in Clinical Implant Dentistry and Related Research.
3. Siddiqi, A, Kieser JA, De Silva, Duncan WJ. Bone-implant contact of Ceramic versus Titanium implants: A histomorphometric analysis. J Dent Res 91(Spec Iss A): abstract # 2575, 2013 (www.dentalresearch.org).
4. Siddiqi A, Kieser JA, De Silva RK, McNaughton A, Duncan WJ. (2012) Could the mid-palate accommodate wide-bodied implants in order to support maxillary over-dentures? A radiomorphometric study of human cadavers. Clinical Oral Implants Research. 00, 2012; 1–9 doi: 10.1111/clr.12050.
5. Osman RB, Ma S, Duncan WJ, De Silva RK, Siddiqi A, Swain MV. (2012) Fractured zirconia implants and related implant designs: scanning electron microscopy analysis. Clinical Oral Implants Research.
6. Siddiqi A, Duncan W, Kieser J, De Sliva RK. (2012) A comparison of trabecular bone micro-architecture in the median palate and maxillary pre-molar alveolar sites of edentulous elderly cadavers: A radiomorphometric study. Abstract in the New Zealand Dental Journal 108: 149.
7. Siddiqi A, Payne AGT, De Silva R, Duncan WJ. (2011) Titanium allergy: could it affect dental implant integration? Clinical Oral Implants Research 22: 673–680.
8. Siddiqi A, Payne AGT, Duncan W, De Silva RK. (2011) Surgical and peri-implant outcomes of ceramic implants supporting overdentures Abstract in New Zealand Dental Journal 107: 30
Public notes

Contacts
Principal investigator
Name 30547 0
Mr Allauddin Siddiqi
Address 30547 0
PhD Student, Oral Implantology Research Group, School of Dentistry, Sir John Walsh Research Institute, University of Otago, Dunedin.
Country 30547 0
New Zealand
Phone 30547 0
+ 64 34795664
Fax 30547 0
Email 30547 0
[email protected]
Contact person for public queries
Name 13794 0
Allauddin Siddiqi
Address 13794 0
PhD Student, Oral Implantology Research Group, School of Dentistry, Sir John Walsh Research Institute, University of Otago, Dunedin.
Country 13794 0
New Zealand
Phone 13794 0
+64 3 4795664
Fax 13794 0
+64 3 4795079
Email 13794 0
[email protected]
Contact person for scientific queries
Name 4722 0
Dr Warwick Duncan
Address 4722 0
Oral Implantology Research Group, School of Dentistry, Sir John Walsh Research Institute, University of Otago, Dunedin.
Country 4722 0
New Zealand
Phone 4722 0
+64 3 4797119
Fax 4722 0
+64 3 4795079
Email 4722 0
warwick.duncan @dent.otago.ac.nz
+64 4 4797110

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