Crestal sinus lift using an implant with an internal L-shaped channel : 1-year after loading results from a prospective cohort study

Purpose: To evaluate the clinical and radiographic outcomes of a one-stage crestal sinus elevation procedure using a self-tapping endosseous implant system (iRaise, Maxillent, Herzliya, Israel) developed for sinus augmentation, 1 year after loading. Materials and methods: Patients needing restoration in the posterior maxilla with a residual alveolar crest of 3 to 8 mm in height and 5 mm in width distal to the canine as measured on CBCT scan were treated using the iRaise sinus lift system. Outcome measures were: implant and prosthetic failures, any complications, increased bone height (iBH), marginal bone loss (MBL), implant stability quotient (ISQ), radiographic tissue remodelling patterns using the sinus grafting remodelling index (SGRI), volumetric measurements of sinus graft, patient self-reported post-surgical swelling, consumption of pain medication and histological analysis. Results: A total of 30 consecutive participants with a mean age of 54.2 ± 9.4 years underwent a transcrestal elevation of the sinus membrane, insertion of bone graft, and implant placement. A total of 50 implants were placed (30 iRaise system implants and 20 adjunctive iSure implants, Maxillent). The mean follow-up was 15.8 ± 2.1 months after implant loading. One patient dropped out at the 1-year after loading follow-up examination. No implants and no prostheses failed during the entire follow-up. One patient experienced a small membrane tear. Before implant insertion, the mean residual alveolar ridge height was 4.64 ± 0.86 mm (range: 3.4-6.4 mm; 95% CI: 4.39-5.01 mm). One year after loading, the bone height was 16.86 ± 3.13 mm (95% CI 15.83-18.07 mm). At the 1-year after loading follow-up, the mean MBL was 0.19 ± 1.05 mm (95% CI 0.02-0.78 mm). The mean ISQ at implant placement was 65.2 ± 5.4 (95% CI 63.6-67.4) and increased during the healing period reaching the mean value of 73.6 ± 3.7 (95% CI 73.1-75.9; range 62-79). The difference was statistically significant (8.4 ± 5.3; 95% CI 5.9-39.7; P = 0.0000). One year after loading, SGRI score was evaluated in 23 implants. Overall, the mean SGRI value was 2.29 ± 2.41 mm (95% CI 1.22-2.98 mm). Bone volume at implant placement was 2.41 ± 0.25 CC (95% CI 2.22-2.48 CC). During the 6-month, submerged healing period, a slight bone contraction of 11.3% were observed. (2.13 ± 0.24 CC;95% CI 2.02-2.26; difference = 0.27 ± 0.25 CC; 95% CI 0.10-0.36; P = 0.0011). At the first year post-loading period, the bone graft remained stable (2.11 ± 0.22 CC; 95% CI 2.02-2.24). The difference was not statistically significant (0.02 ± 0.07 CC; 95% CI 0.01-0.04; P = 0.2166). From the patient's point of view, the mean pain value was 0.52 ± 0.74 (range 0-3); mean swelling value was 0.27 ± 0.52 (range 0-2); and the mean consumption of analgesic was 0.87 ± 4.94 tablets (range 0-4) 3 days after surgery. Morphological and histomorphometric analyses showed that all the samples had a normal structure without inflammatory infiltrate, six months after healing. The following fractions (%) were found: bone (immature bone + mature bone): 44.07 ± 4.91; residual biomaterial: 23.98 ± 2.64; medullary spaces: 31.95 ± 3.16. Conclusions: Sinus floor augmentation can be successfully accomplished with a transcrestal approach using a dedicated implant system. A physiologic contraction of 11.3% of the original volume of the bone graft was experienced during the first 6 months of healing; afterwards, no additional graft volume reduction was observed. Long-term clinical studies are needed to confirm these preliminary results.