ITI dental implants are available with two bone-anchoring surfaces, a titanium plasma-sprayed (TPS) surface, and a recently introduced sandblasted and acid-etched (SLA) surface. Cell culture and animal tests demonstrate that the SLA surface stimulates bone cell differentiation and protein production, has large amounts of bone-to-implant contact, and results in large removal torque values in functional testing of the bone contact. As a result of these studies, a prospective human clinical trial was initiated to determine whether the 4.1 mm diameter SLA ITI solid screw implants could be predictably and safely restored as early as six weeks after implant placement surgery. The protocol restricted the use of the reduced healing time to a) healthy patients with sufficient bone volume to surround the implant, and b) those patients who had good bone quality (classes I-III) at the implant recipient site. Patients with poorer bone quality (class IV) did not have restorations until 12 weeks after implant placement. The clinical trial is an ongoing multicenter trial, with six centers in four countries, and with follow-up over five years. The primary outcome variable was abutment placement with a 35 Ncm force, with no countertorque and no pain or rotation of the implant. A secondary outcome was implant success, as defined by no mobility, no persistent pain or infection, and no peri-implant radiolucency. To date, 110 patients with 326 implants have completed the one-year post-loading recall visit, while 47 patients with 138 implants have completed the two-year recall. Three implants were lost prior to abutment connection. Prosthetic restoration was commenced after shortened healing times on 307 implants. The success rate for these implants, as judged by abutment placement, was 99.3% (with an average healing time of 49 days). Life table analyses demonstrated an implant success rate of 99.1%, both for 329 implants at one year and for 138 implants at two years. In the 24-month period after restoration, no implant losses were reported for the 138 implants. These results demonstrate that, under defined conditions, solid screw ITI implants with an SLA endosseous surface can be restored after approximately six weeks of healing with a high predictability of success, defined by abutment placement at 35 Ncm without countertorque, and with subsequent implant success rates of greater than 99% two years after restoration.

Inadequate bone height in the lateral part of the maxilla forms a contra-indication for implant surgery. This condition can be treated with an internal augmentation of the maxillary sinus floor. This sinus floor elevation, formerly called sinus lifting, consists of a surgical procedure in which a top hinge door in the lateral maxillary sinus wall is prepared and internally rotated to a horizontal position. The new elevated sinus floor, together with the inner maxillary mucosa, will create a space that can be filled with graft material. Sinus lift procedures depend greatly on fragile structures and anatomical variations. The variety of anatomical modalities in shape of the inner aspect of the maxillary sinus defines the surgical approach. Conditions such as sinus floor convolutions, sinus septum, transient mucosa swelling and narrow sinus may form a (usually relative) contra-indication for sinus floor elevation. Absolute contra-indications are maxillary sinus diseases (tumors) and destructive former sinus surgery (like the Caldwell-Luc operation). The lateral sinus wall is usually a thin bone plate, which is easily penetrated with rotating or sharp instruments. The fragile Schneiderian membrane plays an important role for the containment of the bonegraft. The surgical procedure of preparing the trap door and luxating it, together with the preparation of the sinus mucosa, may cause a mucosa tear. Usually, when these perforations are not too large, they will fold together when turning the trap door inward and upward, or they can be glued with a fibrin sealant, or they can be covered with a resorbable membrane. If the perforation is too large, a cortico-spongious block graft can be considered. However, in most cases the sinus floor elevation will be deleted. Perforations may also occur due to irregularities in the sinus floor or even due to immediate contact of sinus mucosa with oral mucosa. Obstruction of the antro-nasal foramen is, due to its high location, not a likely complication, nor is the occurrence of severe haemorrhages since the trap door is in the periphery of the supplying vessels. Apart from these two aspects, a number of anatomical considerations are described in connection with sinus floor elevation.

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Tricalcium phosphate (TCP) has been historically a well-accepted material for bone augmentation. We examined the use of a porous beta-TCP (100%) in a split mouth model for sinus floor augmentation. Five patients were treated bilaterally, receiving 1-2 mm-sized beta-TCP particles (Cerasorb) on one side (test side) and autologous chin bone particles on the other (control) side. Four other patients were treated with a unilateral sinus floor augmentation using 100% beta-TCP (no controls). Biopsies of the augmented sites were taken at 6 months. Histomorphometry measurements were carried out in order to quantify bone augmentation at test and control sides. The average bone volume (BV) formed in the augmented sinus at the control side was 41% (32-56%) and 17% (9-27%) in the test side when all nine patients were included (statistically significant, P=0.04). When only the five bilateral patients were included, mean BV of the test side was 19% (13-27%), which was also significantly different from the control side (P=0.009). Osteoid formation tended to be higher in the test side biopsies (1.3%) than in the controls (0.3%) (marginally significant, P=0.1), indicating ongoing bone formation in the TCP material. The amount of lamellar bone at the test side was less than half the amount in the control side, indicating that remodelling had only recently started in the TCP-augmented side. The resorption surface, however, did not differ significantly between the two sides. These histological results indicate that Cerasorb is an acceptable bone substitute material for augmentation of the maxillary sinus. Due to the osteoconductive, but not osteoinductive properties of this material, the rate of bone formation is somewhat delayed in comparison to autologous bone.

Although a small number of patients were treated, this study provides radiological and histological evidence in humans confirming the suitability of this new BCP for vertical augmentation of the atrophied maxilla by means of a maxillary sinus floor elevation procedure allowing subsequent dental implant placement after a 6-month healing period. The newly formed bone had a trabecular structure and was in intimate contact with the substitute material, outlining the osteoconductive properties of the BCP material. Bone maturation was evident by the presence of lamellar bone.

In this prospective study, the 10-year survival rate at implant and patient level was 99.7% and 99.4%, respectively. Peri-implantitis was present in 7% of the observed dental implants according to the above-mentioned definition of peri-implantitis. This study shows that SLA implants offer predictable long-term results as support in the treatment of fully and partially edentulous patients.

In patients undergoing maxillary sinus floor elevation (MSFE) for dental implant placement, bone substitutes are currently evaluated as alternatives for autologous bone. However, bone substitutes have only osteoconductive properties and lack osteoinductive potential. Therefore, this phase I study evaluated the potential additive effect on bone regeneration by the addition of freshly isolated, autologous but heterologous stromal vascular fraction (SVF), which is highly enriched with adipose stromal/ stem cells when compared with native adipose tissue. From 10 patients, SVF was procured using automatic processing, seeded on either b-tricalcium phosphate (n = 5) or biphasic calcium phosphate carriers (n = 5), and used for MSFE in a one-step surgical procedure. Primary objectives were feasibility and safety. The secondary objective was efficacy, evaluated by using biopsies of the augmented area taken 6 months postoperatively, concomitant with dental implant placement. Biopsies were assessed for bone, graft, and osteoid volumes. No adverse effects were reported during the procedure or follow-up ( ‡3 years). Bone and osteoid percentages were higher in study biopsies (SVF supplemented) than in control biopsies (ceramic only on contralateral side), in particular in b-tricalcium phosphatetreated patients. Paired analysis on the six bilaterally treated patients revealed markedly higher bone and osteoid volumes using microcomputed tomography or histomorphometric evaluations, demonstrating an additive effect of SVF supplementation, independent of the bone substitute. This study demonstrated for the first time the feasibility, safety, and potential efficacy of SVF seeded on bone substitutes for MSFE, providing the first step toward a novel treatment concept that might offer broad potential for SVF-based regenerative medicine applications. STEM CELLS TRANSLATIONAL MEDICINE 2016;5:1362-1374

Both beta-TCP and mandibular bone grafts resulted in radiographic reduction of the vertical height over the 5-year period following maxillary sinus floor elevation. After an initial height reduction in the first 1.5 year, subsequent changes were minimal. No significant differences were observed between the two types of grafting material. There was no statistically significant difference in reduction between the three locations for vertical bone height and graft height, respectively.