View clinical trials related to Sinus Floor Augmentation.
Filter by:The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.
Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.
Background: Implant placement in the posterior maxilla is always troubled by the insufficient bone volume. Trans-alveolar sinus floor elevation (TSFE) has been proven a predictable surgical procedure to increase the bone height in the posterior maxilla. However, questions as the necessity of the bone grafting is necessary during the sinus lift and could the TSFE be performed when the residual bone height is below 5mm are still being debated. Besides, high-quality evidence on comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited. Methods/Design: 120 adult patients who fit the inclusion criterions are being recruited from the first clinical division, School and Hospital of Peking University (Beijing, China). All the patients are assigned into four groups according a table of random numbers. Participants receive 1) TSFE using osteotomes with bone grafting; 2) TSFE using osteotomes without bone grafting; 3) modified TSFE with bone grafting; and 4) modified TSFE without bone grafting. The clinical operators will be concealed with the assignment until the beginning of surgical procedures. In a one year follow up period, implant survival rates, complications, implant stability, bone remodeling around the implant and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) are observed and documented. The implant stability is gauged by the resonance frequency analysis for 7 times (2, 4,8,12,16,26,52 weeks). And the bone remodeling is observed and compared by CT scan. Discussion: The result of the trial will support a better decision making in atrophy posterior maxilla when implant placement is needed. If favorable, the use of the modified TSFE would achieve as ideal outcome as the traditional TSFE but with less trauma and postoperative discomforts. Besides, whether the bone graft procedure is necessary for the TSFE will also be discussed.