Abstract
ObjectivesTo assess the osseointegration and crestal bone level maintenance of a novel fully tapered self-cutting tissue-level implant for immediate placement (test) compared to a clinically established tissue-level implant (control) in moderate bone quality.Materials and methodsTest and control implants were compared in 3 groups, i.e., small-, medium-, and large-diameter implants in an edentulous mandibular minipig model with moderate bone quality after 12 weeks of healing. Histometrically derived bone-to-implant contact (BIC) and first bone-to-implant contact (fBIC) were subjected to statistical non-inferiority testing. Maximum insertion torque values in artificial bone were assessed for comparison.ResultsBIC values for the tests and control implants for all 3 diameters were comparable and non-inferior: small diameter (61.30 ± 10.63% vs. 54.46 ± 18.31%) (p=0.99), medium diameter (60.91 ± 14.42 vs. 54.68 ± 9.16) (p=0.55), and large diameter (45.60 ± 14.67 vs. 52.52 ± 14.76) (p=0.31). fBIC values for test implants were higher and non-inferior compared to control implants in all three groups. Test implants further showed distinctly higher maximum insertion torque values compared to control implants.ConclusionThe investigated novel tissue-level implant is able to achieve high levels of primary and secondary implant stability under simultaneous preservation of crestal bone levels. This qualifies the studied implant as an attractive candidate for immediate placement in bone of limited quality.Clinical relevanceThis pilot pre-clinical study investigated a novel tissue-level implant for immediate placement. With the aim of translating the studied prototype into clinical application pre-clinical models, procedures and controls have been chosen with the aim of reflecting its future clinical indication and use.
Highlights
Tissue-level implants represent one of the earliest and wellestablished treatment concepts in implant dentistry
The key characteristic in this implant design is a protruding thread geometry, which allows the surrounding bone to be condensed and at the same time, limits excessive stress on the cortical bone by a process termed active bone management [17]. Within this pre-clinical study, we have evaluated a further extension of this design concept into a fully tapered selfcutting tissue-level implant for immediate placement
Control group data for the small-diameter implants was reduced to n=7 due to limited space of the edentulous implantation site in one animal noted during surgery
Summary
Tissue-level implants represent one of the earliest and wellestablished treatment concepts in implant dentistry. Compared to submerged treatment concepts, tissuelevel implants require a reduced number of surgical procedures and chair-time for the patient [1]. Bone level implants may potentially provide higher prosthetic flexibility, tissue-level implants still represent a treatment concept which can be considered equivalent in terms of osseointegration, better in crestal bone level preservation and equivalent with regards to long-term survival rates [2, 3]. A key characteristic that may have contributed to the long-term clinical success of tissue-level implants and the crestal bone preservation is the relocation of this microgap away from the bone level [4,5,6]
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