Osteotome sinus floor elevation without grafting material: a 1-year prospective pilot study with ITI implants

OBJECTIVE: The aim of the present pilot study was to evaluate: (1) the predictability of an osteotome sinus floor elevation procedure with ITI-SLA implants without placing a bone grafting material, and (2) the possibility to gain bone height without filling the created space with a bone grafting material. MATERIAL AND METHODS: Seventeen patients received 25 implants protruding in the sinus. Most implants (21/25) were 10 mm long, eight were inserted in type 2 bone, 12 in type 3 and five in type 4 bone. At implant placement, the mean residual bone height (RBH) under the maxillary sinus was 5.4+/-2.3 mm; it was 5.7+/-2.6 mm on the mesial side and 5.1+/-1.9 mm on the distal side. Nineteen implants had less than 6 mm of bone on at least one side and six implants had less than 6 mm on both sides. A healing period of 3-4 months was allowed before abutment tightening at 35 Ncm. The percentage of stable implants at abutment tightening and at the 1-year control was calculated. The endo-sinus bone gain and the crestal bone loss (CBL) at the mesial and distal sides were measured. RESULTS: Abutments were tightened after 3.1+/-0.4 months. All implants but one (96%) resisted the applied 35 Ncm torque. At the 1-year control, all implants were clinically stable and supported the definitive prosthesis. All showed endo-sinus bone gain; the mean gain was 2.5+/-1.2 mm. The mean CBL was 1.2+/-0.7 mm. Endo-sinus bone gain and RBH showed a strong negative correlation (r=-0.78 on the mesial side and -0.80 on the distal side). A good correlation (r=0.73) was found between implant penetration in the sinus and endo-sinus bone gain. CONCLUSION: Elevation of the sinus membrane alone without addition of bone grafting material can lead to bone formation beyond the original limits of the sinus floor. Despite a limited RBH at implant placement, a healing period of 3 months was sufficient to resist a torque of 35 N cm and to lead to a predictable implant function at the 1-year control.