This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with: * Resistance to countertorque testing (mobility) * Implant Stability Quotient (ISQ) * Changes in peri-implant crestal bone levels * Confirmation of clinical benefits A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)
Hospital San Jose
Providencia, Santiago Metropolitan, Chile
Dr. George Papavasiliou
Athens, Greece
Implant survival
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
Time frame: 2 years
Peri-implant crestal bone levels
Assessed by radiographic measurements of serial crestal bone levels
Time frame: 2 years
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