straumann bone ceramic versus biooss in sinus elevation

Conditions: Jaw, Edentulous, Partially; Alveolar Bone Loss

Summary: straumann bone ceramic (sbc) and biooss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. the patients are followed for 3 years.the study hypothesis is that the sbc is not worse than biooss.

straumann bone ceramic (sbc) and biooss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. the bone grafting materials will be placed into the sinus cavity,(a routine procedure), one material randomly at each side and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed and a regular straumann slactive implant is inserted. the micro-implant is evaluated histologically. the site is evaluated every 12 months for 3 years in regards to clinical measurements. the study hypothesis is that the sbc is not worse than biooss. study design: prospective, randomized, open, controlled, single center, split mouth study population: 11 male and female patients at an age of between 18 and 80 years, affected by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited in the study and treated by means of maxillary sinus floor augmentation and delayed implant placement.

Eligibility criteria:
inclusion criteria: * males and females, 18 years to 80 years of age * the patients are at least partly edentulous in the both maxillary regions corresponding to the sinuses. * a dental implant procedure is foreseen in both maxilla regions corresponding to maxillary sinuses. * patients must be expected to present a bilateral bone defect in the sinus area, which both need a sinus floor augmentation to place one or more dental implants each. * residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of each of the maxillary sinuses shall be * less than 5 mm and at least 2 mm, as measured by scanora - tomography scans in the deepest floor of the sinus * residual alveolar crest width should be at least in average more than 4mm as measured by scanora - tomography scans * patients must be committed to the study and must sign informed consent. * oral hygiene index less than 25% exclusion criteria: * any systemic medical condition that could interfere with the surgical procedure or planned treatment * current pregnancy at the time of recruitment * physical handicaps that would interfere with the ability to perform adequate oral hygiene * alcoholism or chronically drug abuse causing systemic compromize * patients who smoke more than 10 cigarettes per day * medication which interferes with bone formation * conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability * mucosal diseases such as erosive lichen planus * history of local radiation therapy * presence of oral lesions (such as ulceration, malignancy) * severe bruxing or clenching habits * persistent intraoral infection * previous gbr (bone graft) or dental implant treatment in the posterior segments of the upper maxilla (foreseen implant site) * patients presenting clinical and radiological signs and symptoms of maxillary sinus disease * existing teeth in the residual dentition with untreated endodontic problems

Keywords: bone grafting sinus elevation sinus augmentation