None listed
Conditions
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
Interventions
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 surge
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.
Sponsors
Southern Implants (Ltd)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed