Luongo, Giuseppe

Purpose: To investigate and compare the production tolerances of six different commercially available implant scan bodies (SBs), with the null hypothesis that there would be no tolerances or significant differences between the different SBs. Materials and Methods: Six different implant SBs (IO 6A-B and IO 2B-B, Nobel Biocare; RC 4.1 mm 025.4915 and RN 4.8 mm 048.168, Straumann; KR 352KR1A0, BTK Dental Implants; and AANISR4013T, MegaGen) were evaluated. Five specimens of each SB type (total N = 30 samples) were screwed onto the corresponding implant analogs and underwent dimensional analysis with optical microscopy (QVI Smartscope Flash 200, Optical Gaging Products) and precision probing (R 0.25, Renishaw). The outcome variables were SB height, diameter, and angle of the flat face on the top (plane). All measurements were compared to the corresponding computer-assisted design library measurements as a reference to assess the tolerances. Statistical analyses were performed to compare the results obtained with the different SBs. Results: Tolerances in the manufacturing of the SBs were reported in height, diameter, and plane measurements, and statistically significant differences between the different types of SBs were found. Therefore, the null hypothesis was rejected. Most of the deviations and tolerances were reported in height measurements with conical connection implants. Conclusions: Production tolerances and statistically significant differences were found among the six commercially available SBs evaluated in this study. Additional studies with larger sample sizes and other types of SBs are needed.

This prospective longitudinal clinical trial aimed to evaluate the success of a bone-level implant with an integrated platform-switched connection by assessing peri-implant soft tissue and marginal bone level. Twenty-six patients were treated in two different centers with implants placed in healed partially edentulous ridges. Implant success rate and marginal bone level were evaluated with photographs, radiographs, and clinical measurements, with a 6-month postloading follow-up. The esthetic appearance of the photographed periimplant soft tissue was evaluated at 6 months via the Pink Esthetic Score applied by two calibrated operators. All of the implants except for one placed in the mandible demonstrated successful osseointegration, resulting in a success rate of 97.8% at the 6-month follow-up. Compared to historical controls, no detectable differences in peri-implant marginal bone loss or esthetic outcome were seen.

To accurately assess the long-term performance of anodized-surface implants, more data monitoring is needed outside of clinical evaluations. This retrospective study evaluated long-term implant survival and bone remodeling after up to 12 years of function. Data from 195 implants placed in 60 patients over a follow-up period ranging from 0.6 to 12.1 years were included. The implantlevel survival rate was 99.0%. Marginal bone loss remained low across all follow-up cohorts. The data show that anodized-surface implants are a safe, reliable option with high implant survival rates and low levels of bone loss.

Purpose: To evaluate the influence of at least three abutment disconnections in conventional loaded implants against placement of a definitive abutment in immediately non-occlusal loaded implants on hard and soft tissue changes. A secondary aim was to evaluate whether the presence of less than 2 mm of keratinised mucosa is associated with increased peri-implant marginal bone loss and soft tissue recessions. Materials and methods: Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised, after implants were placed with more than 35 Ncm, according to a parallel group design to receive definitive abutments that were loaded immediately (definitive abutment or immediate loading group) or transmucosal abutments, which were delayed loaded after 3 months and removed at least three times: 1. At impression taking (3 months after implant placement); 2. When checking the zirconium core on titanium abutments at single crowns or the fitting the metal structure at prostheses supported by multiple implants; 3. At delivery of the definitive prostheses (repeated disconnection or conventional loading group). Patients were treated at four centres and each patient contributed to the study, with only one prosthesis followed for 3 years after initial loading. Outcome measures were: prosthesis failures, implant failures, complications, pink aesthetic score (PES), buccal recessions, patient satisfaction, peri-implant marginal bone level changes and height of the keratinised mucosa. Results: Forty patients were randomly allocated to each group according to a parallel group design. Six patients from the definitive abutment group dropped out or died, and one left from the repeated disconnection group. One implant, from the repeated disconnection group, fractured (difference = 3%; CI 95%: -2%, 8%; P = 1). Four provisional crowns and one definitive single crown had to be remade because of poor fitting, and one definitive crown and one definitive prosthesis because of ceramic and implant fracture, respectively, in the repeated disconnection group vs one provisional prosthesis from the definitive abutment group due to frequent debondings (difference = 15%; CI 95%: 2%, 28%; P = 0.060). Five patients from the definitive abutment group and four patients from the repeated disconnection group were affected by complications (difference = 4%; CI 95%: -11%, 20%; P = 0.725). PES scores assessed at 3 years post-loading were 11.7 (standard deviation = 1.8) mm for the definitive abutment group and 11.3 (1.5) mm for the repeated abutment changes group (difference = 0.4; CI 95%: -0.4, 1.2; P = 0.315). However, there was a difference of 0.26 out of a maximum score of 2 in favour of the definitive abutment group for soft tissue contour only. Buccal recessions at 3 years post-loading amounted to -0.1 (0.8) mm for the definitive abutment group and -0.1 (1.2) mm for the repeated abutment changes group (it was actually a soft tissue gain; difference = 0.01 mm CI 95%: -0.48, 0.50; P = 0.965). All patients declared being very satisfied or satisfied with the function and aesthetics of the prostheses and said they would undergo the same procedure again, with the exception of one patient from the repeated disconnection group who was uncertain regarding function. Mean peri-implant marginal bone loss 3 years after loading was 0.07 (0.18) mm for the definitive abutment group and 0.50 (0.93) mm for the repeated abutment changes group (difference = 0.43 mm; CI 95%: 0.13, 0.74; P = 0.007). The height of keratinised mucosa at 3 years post-loading was 2.8 (1.3) mm for the definitive abutment group and 2.8 (1.6) mm for the repeated abutment changes group (difference = 0.03; CI 95%: -0.67, 0.73; P = .926). Up to 3 years after initial loading there were no statistically significant differences between the two procedures, with the exception of 0.4 mm more marginal bone loss at implants subjected to three abutment disconnections. There were no significantly increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Conclusions: Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Keywords: dental implant, immediate loading, keratinised mucosa, peri-implant marginal bone levels, repeated abutment disconnections Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

Purpose: To evaluate the influence of at least three abutment changes in conventionally loaded implants against placement of a definitive abutment in immediately non-occlusal loaded implants on hard and soft tissue changes. Materials and methods: Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised, after implants were placed with more than 35 Ncm, according to a parallel group design to receive definitive abutments which were loaded immediately (definitive abutment or immediate loading group) or transmucosal abutments. These were delayed loaded after 3 months and were removed at least three times: 1) at impression taking (3 months after implant placement); 2) when checking the zirconium core on titanium abutments at single crowns or the fitting the metal structure at prostheses supported by multiple implants; 3) at delivery of the definitive prostheses (repeated disconnection or conventional loading group). Patients were treated in four centres and each patient contributed to the study with only one prosthesis followed for 1 year after initial loading. Outcome measures were: prosthesis failures, implant failures, complications, pink esthetic score (PES), buccal recessions, patient satisfaction, peri-implant marginal bone level changes and height of the keratinised mucosa. Results: Forty patients were randomly allocated to each group according to a parallel group design. Two patients dropped out from the definitive abutment group but no implant failed. Four provisional and one definitive single crowns had to be remade (due of misfitting) and one definitive crown (due to ceramic fracture) in the repeated disconnection group versus one provisional prosthesis of the immediate loading group due to frequent debondings (difference = 12%; CI95%: 0%, 25%; P = 0.109). Eight patients were affected by complications: four patients from each group (difference = 1%; CI95%: -13%, 14%; P = 1). PES scores assessed at 1 year post-loading were 11.4 (1.5) mm for the definitive abutment group and 11.0 (2.0) mm for the repeated abutment changes group (difference = 0.4; CI95%: -0.4, 1.2; P = 0.289). Buccal recessions at 1 year post-loading amounted to 0.07 (0.35) mm for the definitive abutment group and 0.12 (0.65) mm for the repeated abutment changes group (actually it was a soft tissue gain; difference = 0.05 CI 95%: -0.19, 0.29; P = 0.659). All patients declared to be very satisfied or satisfied with the function and aesthetics of the prostheses and would undergo the same procedure again. Mean peri-implant marginal bone loss at 1 year after loading was 0.06 (0.12) mm for the definitive abutment group and 0.23 (0.49) mm for the repeated abutment changes group (difference = -0.16; CI95%: -0.33,-0.00; P = 0.046). The height of the keratinised mucosa at 1 year post-loading was 2.8 (1.5) mm for the definitive abutment group and 2.8 (1.7) mm for the repeated abutment changes group (difference = -0.0; CI 95%: -0.8, 0.7); P = 0.966. Up to 1 year after initial loading, there were no statistically significant differences between the two procedures, with the exception of 0.16 mm more marginal bone loss at implants subjected to three abutment removals. Conclusions: One-year post-loading data showed that repeated abutment changes significantly increased bone loss of 0.16, but this difference cannot be considered clinically relevant, therefore clinicians can use the procedure they find more convenient for their specific patient. In addition, immediately non-occlusally loaded dental implants are a viable alternative to conventional loading. Keywords: dental implant, immediate loading, peri-implant marginal bone levels, repeated abutment changes Conflict-of-interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results with exception of rejecting the proposal of changing the protocol, after the trial was started, allowing the use of indexed abutments.

The aim of this prospective multicenter study was to evaluate the outcomes of single implants subjected to immediate functional loading. Inclusion criteria were single-tooth placement in postextraction sockets or fully healed sites, and sufficient bone height and width to place an implant of at least 3.5 × 10.0 mm. All implants were functionally loaded immediately after placement and followed for 2 years. Outcome measures were implant survival, complications, and periimplant marginal bone loss (MBL). A total of 57 implants (38 maxilla, 19 mandible) were placed in 46 patients (23 men, 23 women, aged 18-73 years). Of these, 10 implants were placed in postextraction sockets. One implant failed, in a healed site, giving a patient-based overall 2-year survival rate of 97.6%. The incidence of biologic complications was 1.8%; prosthetic complications amounted to 7.5%. The peri-implant MBL was 0.37 ± 0.22 mm (healed sites: 0.4 mm ± 0.22; postextraction sockets: 0.3 mm ± 0.22). The immediate functional loading of single implants seems to represent a safe and successful procedure. Long-term followup studies on a larger sample of patients are needed to confirm these results.

Purpose: To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). Materials and methods: A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. Results: In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone. Conclusions: No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Keywords: dental implant, effectiveness, follow-up Conflict-of-interest statement: This research project was originally funded by Keystone Italia, Dental spa (Verona, Italy), the manufacturer of the implants evaluated in this investigation. However, when Keystone Italia received the data of the present manuscript, they refused to honour the financial agreement for the present publication. Therefore, no further follow-ups of this trial will be considered. A legal action was initiated against Keystone Italia. The data belonged to the authors and by no means was the manufacturer allowed to interfere with the conduct of the trial or the publication of the results.

Purpose: To evaluate the influence of at least three abutment changes against the placement of a definitive abutment, which was no longer removed, on hard and soft tissue changes, and to compare the clinical outcomes of immediate non-occlusal loading versus conventional loading. Materials and methods: Eighty patients requiring one single crown or one fixed partial prosthesis supported by a maximum of three implants were randomised, after implants were placed with more than 35 Ncm, according to a parallel group design to receive definitive abutments which were loaded immediately (definitive abutment or immediate loading group) or transmucosal abutments which experienced delayed loading after 3 months and were removed at least three times: 1) during the making of the impression (3 months after implant placement); 2) when checking the zirconium core of titanium abutments at single crowns or the fitting of the metal structure at prostheses supported by multiple implants; 3) at delivery of the definitive prostheses (repeated disconnection or conventional loading group). Patients were treated in four centres and each patient contributed to the study with only one prosthesis followed for 4 months after initial loading. Outcome measures were: prosthesis/implant failures, any complication, peri-implant marginal bone level changes, and patient satisfaction. Results: Forty patients were randomly allocated to each group according to a parallel group design. No patient dropped-out and no implants failed. However four provisional prostheses and one definitive prosthesis had to be remade because of misfitting (five single crowns) in the repeated disconnection group; and one provisional prosthesis had to be remade because of frequent debondings in the immediate loading group (difference = 10%; 95% CI: -1%, 21%; P = 0.109). Five complications (all debondings of the provisional prostheses) were reported in two patients of the immediate loading group, in comparison to three biological complications in three patients of the repeated disconnection group (difference = 2%; 95% CI: -8%, 13%; P = 1). All patients were very satisfied or satisfied with the function and aesthetics of the prostheses, and would undergo the same procedure again. Mean peri-implant marginal bone loss 4 months after loading was -0.08 (0.16) mm for the definitive abutment group and -0.09 (0.20) mm for the repeated abutment changes group (difference = 0.01; 95% CI: -0.07, 0.09; P = 0.97). There were no statistically significant differences for any of the outcome measures between the two procedures up to 4 months after initial loading. Conclusions: Preliminary short-term data (4-month post-loading) showed that repeated abutment changes do not alter bone levels significantly. Immediate non-occlusal loading of dental implants are a viable alternative to conventional loading. Therefore clinicians can use the procedure they find more convenient for their specific patient. Keywords: dental implant, immediate loading, peri-implant marginal bone levels, repeated abutment changes