Recombinant human bone morphogenetic protein-7 in maxillary sinus floor elevation surgery in 3 patients compared to autogenous bone grafts. A clinical pilot study.

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This pilot study was designed to determine the clinical bone formation ability of a human recombinant DNA bone morphogenetic protein-7, also referred to as Osteogenic Protein-1 [OP-1] combined with a collagen carrier, implanted in the maxillary sinus of 3 patients. The results were compared with a group of 3 patients treated with sinus floor elevation and autogenous bone grafts. 6 consecutive patients, 4 female and 2 male, between 48 and 57 years of age were treated by means of sinus floor elevation for insufficient bone height in the posterior maxilla for implant surgery. 3 patients, 2 female and 1 male, were treated with OP-1 attached to a collagen device. In these patients, 4 maxillary sinus grafting procedures according to Tatum's method were carried out. 1 g of collagen carrier containing 2.5 mg rhOP-1 mixed with 3 ml of saline was placed between the bony floor and the elevated mucosal lining of the most caudal part of the maxillary sinus, in order to increase the vertical bone dimension to place dental implants of a sufficient length. The 3 other patients, also 2 female and 1 male, with a total of 5 sinus sites, were treated with sinus floor elevation and autogenous iliac crest bone grafts. After 6 months, during dental implant preparation, bone cores were taken for histology. Thus, clinical, radiological and histological results of the 2 groups of 3 patients were compared. 6 months after sinus grafting with OP-1, in 1 male, well-vascularized bone-like tissue of good quality was observed clinically. This could be confirmed by histology. In the second, female, patient no bone formation was observed at all. A cyst-like granular tissue mass, without purulent content, was removed. In the 3rd, female, patient, who received bilateral sinus grafts, some bone-like formation was seen, however it showed flexible tissue which led to the decision that at 6 months after the sinus grafting, the implant placement had to be postponed. In all 5 autogenous grafted sinuses a bone appearance similar to normal maxillary bone was observed clinically as well as histologically and dental implants could be placed six months after sinus floor elevation surgery. These findings indicate that the OP-1 device has the potential for initiating bone formation in the human maxillary sinus within 6 months after a sinus floor elevation operation. However, the various findings in these 3 patients indicate that the behaviour of the material is at this moment insufficiently predictable, in this indication area. Further investigation is indicated before OP-1 can be successfully used instead of the "gold standard" autogenous bone graft.