Bone Regeneration Using a Hollow Hydroxyapatite Space-Maintaining Device for Maxillary Sinus Floor Augmentation - A Clinical Pilot Study

Background: The mere lifting of the maxillary sinus membrane by implants protruding into the sinus cavity allows the establishment of a void space for blood clot and new bone formation. Purpose: To evaluate bone formation by using a spherical, hollow, and perforated hydroxyapatite space-maintaining device (HSMD) in a two-stage sinus lift procedure where residual alveolar bone height was =2 mm. Material and Methods: Spherical, hollow, and perforated HSMDs with a diameter of 12 mm were manufactured for this pilot study. Three patients with a residual bone height of 12 mm, as verified clinically and radiographically, and in need of a sinus augmentation procedure prior to implant installation were selected for the study. The HSMD and bone formation was evaluated by cone beam computerized tomography (CBCT) 6 months after augmentation procedure. Implants were installed 6 to 9 months after augmentation. The implant sites were prepared by a trephine drill to obtain a specimen of HSMD and bone for histological evaluation. After implant installation, the condition of the sinus membrane adjacent to the HSMD was evaluated endoscopically. After an additional 8 weeks, fixed partial prostheses were fabricated. Results: Bone formation verified by CBCT was found around and inside the device in all three patients after 6 months. Despite the fact that residual bone before augmentation was =2 mm, 12-mm-long implants with diameter of 4.8 mm could be inserted with preservation of an intact and healthy sinus membrane verified endoscopically. Bone formation inside HSMDs was noted histologically in two out of three HSMDs. Implants were stable and without any marginal bone loss after 1 year of prosthetic loading. Conclusion: A spherical, hollow, and perforated HSMD used in sinus lift procedures can produce a void space for blood clot and new bone formation and subsequent implant installation.