Osteotome sinus floor elevation with or without grafting: a preliminary clinical trial.

OBJECTIVES This clinical trial aimed (1) to evaluate the predictability of the osteotome sinus floor elevation (OSFE) technique, (2) to study the influence of simultaneous grafting on the clinical success of placing dental implants in the posterior maxilla using OSFE and (3) to observe the bone changes in the elevated space with OSFE without grafting. MATERIAL AND METHODS Two hundred and eighty Straumann implants were placed in the posterior maxillae of 202 patients using OSFE. One hundred and ninety-one implants were placed in 125 patients without grafting. The implants were allowed to heal for 3-4 months for non-grafted implants and for 6-8 months for grafted cases. For radiographic analyses, periapical and panoramic radiographs were taken of 30 implants at 3 and 9 months to assess the bone changes for the elevated sites without grafting. RESULTS Two hundred and sixty-eight of 280 implants fulfilling the survival criteria represented a cumulative survival rate of 95.71%. The residual bone height (RBH) was 5.6+/-2.5 mm for the non-grafted group and 4.7+/-2.1 mm for the grafted group. The perforation rate was 4.29%. No significant differences were found between the two groups in RBH, survival rate or membrane perforation rate. The radiographic analyses demonstrated that new bone formation in the elevated sinus was visible and the endo-sinus bone gain was 2.26+/-0.92 mm and 2.66+/-0.87 mm at 3- and 9- month follow-up, respectively. Crestal bone loss (CBL) was 0.89+/-0.5 and 1.2+/-0.48 mm at 3 and 9 months. For the two test groups, RBH did not have a significant influence on the survival of the implants. At the 9-month follow-up, the endo-sinus bone gain and CBL were not significantly correlated to RBH. The implant protrusion length was significantly correlated to the endo-sinus bone gain. CONCLUSIONS The findings of this study indicated that uneventful osseointegration may be predictable on applying OSFE whether with or without grafting in atrophic posterior maxilla. Spontaneous new bone formation seemed to be expected with implants placed using OSFE without simultaneous grafting.