Primary and Secondary Stability Characteristics of a Novel Ceramic Implant

Objectives: The objective of the present study was to show that a novel ceramic, 2-piece bone level implant is non-inferior to a titanium implant of identical outer geometry with the same design in terms of osseointegration in a controlled preclinical trial.
Methods: Six female adult Göttingen Minipigs were included in this study. In a first surgery the lower premolars and the first molar were extracted bilaterally. After a healing period of three months the ridge was exposed. Six implants were placed per animal according to the manufacturers guidelines. Three ceramic implants (NCIS, Neodent) were placed in one hemi-mandible and three titanium implants (Alvim, Neodent) were placed on the contralateral hemi-mandible. All animals were sacrificed after a healing period of eight weeks. The maximum insertion torque values (maxIT), total bone to implant contact (BIC), first bone to implant contact (fBIC) and bone density in two different regions of interest were measured for each implant.
Results: A significantly lower maximum insertion torque was measured for the ceramic compared to the titanium implant. A trend towards less peri-implant bone loss of the ceramic implant compared to the titanium implant was observed. The total bone to implant contact was highly comparable between the two implant types. A significantly higher total BATA in the apical ROI was measured for the ceramic implant compared to the titanium implant. The values in the coronal ROI are highly comparable between both implant types.
Conclusions: It was shown that the maximum insertion torque values for the ceramic implant was significantly lower compared to the titanium implant despite identical design and drill protocol used. All histological measurements were highly comparable between the two implant types except the bone density around the apical part of the ceramic implants which was significanlty higher compared to the titanium implants. Under the conditions of the present study it could be shown that the novel ceramic implant is non-inferior to its titanium-based predicate device.