On guided bone reformation in the maxillary sinus to enable placement and integration of endosseous implants. Clinical and experimental studies.

Abstract: Dental caries and periodontal disease are the major causes for tooth loss. While dental caries commonly involve the posterior teeth in both jaws, the teeth most commonly lost due to periodontal problems are the first and second molars in the maxilla. As a consequence, the upper posterior jaw is frequently edentulous. Implant therapy today is a predictable treatment modality for prosthetic reconstruction of edentulous patient. Insufficient amounts of bone, due to atrophy following loss of teeth or due to the presence of the maxillary sinus, can make it impossible to insert implants in the posterior maxilla. During the 1970s and 1980s, Tatum, Boyne and James and Wood and Moore first described maxillary sinus floor augmentation whereby, after the creation of a lateral access point, autologous bone grafts are inserted to increase crestal bone height and to create the necessary conditions for the insertion of implants. This surgical procedure requires a two-stage approach and a double surgical site: first, bone is harvested from a donor site and transplanted to the recipient site; then, after a proper healing period of between 4 to 6 months, the implants are inserted. This kind of bone reconstruction, even if well documented, has its limitations, not least in the creation of two different surgical sites and the consequent increased risk of morbidity. In 2004, Lundgren et al. described a new, simplified technique for the elevation of the sinus floor. The authors showed that by lifting the sinus membrane an empty space was created in which blood clot formations resulted in the establishment of new bone. The implants were placed simultaneously to function as “tent poles”, thus maintaining the sinus membrane in a raised position during the subsequent healing period. An essential prerequisite of this technique is to obtain optimal primary implant stability from the residual bone in the sinus floor. An extremely resorbed maxillary sinus floor, with, for example, less than 2-3 mm of poor quality residual bone, could impair implant insertion.The aims of the present research project were (i) to evaluate the donor site morbidity and the acceptance level of patients when a bone graft is harvested from the anterior iliac crest, (ii) to evaluate implant stability, new bone formation inside the maxillary sinus and marginal bone resorption around the implants in long term follow up when maxillary sinus floor augmentation is performed through sinus membrane elevation and without the addition of any grafting material, (iii) to investigate new bone formation inside the maxillary sinus, in experimental design, using a resorbable space-maker device in order to maintain elevation of the sinus membrane where there is too little bone to insert implants with good primary stability.In Paper I, 70 consecutively treated patients were retrospectively evaluated in terms of postoperative donor site morbidity and donor site complications. With regard to donor site morbidity, 74% of patients were free of pain within 3 weeks, whereas 26% had a prolonged period of pain lasting from a few weeks to several months. For 11% of patients there was still some pain or discomfort 2 years after the grafting surgery. Nevertheless, patients acceptance was high and treatment significantly improved oral function, facial appearance, and recreation/social activities and resulted in an overall improvement in the quality of life of formerly edentulous patients.In Paper I and III, some differently shaped space-making devices were tested on primates (tufted capuchin - Cebus apella) in two experimental models aimed at evaluating whether a two-stage procedure for sinus floor augmentation could benefit from the use of a space-making device to increase the bone volume and enable later implant installation with good primary stability, without the use of any grafting material. An histological examination of the specimens showed that it is possible to obtain bone formation in contact with both the Schneiderian membrane and the device. In most cases the device was displaced. The process of bone formation indicated that this technique is potentially useful for two-stage sinus floor augmentation. The lack of device stability within the sinus requires further improvement in space-makers if predictable bone augmentation is to be achieved.In Paper IV, a total of 84 patients were subjected to 96 membrane elevation procedures and the simultaneous placement of 239 implants. Changes of intra-sinus and marginal bone height in relation to the implants were measured in intraoral radiographs carried out during insertion after 6 months of healing, after 6 months of loading and then annually. Computerised tomography was performed pre-surgically and 6 months post-surgically. Resonance frequency analysis measurements were performed at the time of implant placement, at abutment connection and after 6 months of loading. The implant follow-up period ranged from a minimum of one to a maximum of 6 years after implant loading. All implants were stable after 6 months of healing. A total of three implants were lost during the follow-up period giving a survival rate of 98.7%. Radiography demonstrated an average of 5.3 ± 2.1 mm of intra-sinus new bone formation after 6 months of healing. RFA measurements showed adequate primary stability (implant stability quotient 67.4 ± 6.1) and small changes over time.In conclusion, harvesting bone from the iliac crest could result in temporary donor site morbidity, but in 11% of patients pain or discomfort was still present up to 2 years after surgery. However, patient satisfaction was good despite this slow or incomplete recovery, as showed by the quality of life questionnaire. Maxillary sinus membrane elevation without the use of bone grafts or bone substitutes results in predictable bone formation both in animal design, where the sinus membrane is supported by a resorbable device, and in clinical conditions, where the membrane is kept in the upper position by dental implants. This new bone formation is accompanied by a high implant survival rate of 98.7% over a follow-up period of up to 6 years. Intra-sinus bone formation remained stable in the long-term follow-up. It is suggested that the secluded compartment allowed bone formation in accordance with the principle of guided tissue regeneration. This technique reduces the risks of morbidity related to bone graft harvesting and eliminates the costs of grafting materials.