Clinical evaluation of modified transalveolar sinus floor elevation and osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial

Abstract

BackgroundImplant placement in the posterior maxilla is often complicated by the insufficient bone volume. While transalveolar sinus floor elevation (TSFE) has been proven as a predictable surgical procedure to increase the bone height in the posterior maxilla, questions in regard to the necessity of the bone grafting during the sinus lift and the question of whether TSFE could be performed when the residual bone height is below 5 mm are still debated. Furthermore, high-quality evidence comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited.Methods/designOne hundred twenty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology First Clinical Division (Beijing, China). All patients are assigned to one of four groups according to a table of random numbers. Participants will receive (1) TSFE using osteotomes with bone grafting, (2) TSFE using osteotomes without bone grafting, (3) modified TSFE with bone grafting, or (4) modified TSFE without bone grafting. In a one-year follow-up period, implant survival rates, complications, implant stability, bone remodeling around the implant, and patient-reported outcome (visual analog scale for intraoperative discomfort and postoperative pain) will be observed and documented. The implant stability will be gauged by the resonance frequency analysis six times (at baseline and weeks 6, 8, 12, 16, and 26), and the bone remodeling will be observed and compared via radiographic examinations.DiscussionThe result of the trial will potentially contribute to better decision making in atrophic posterior maxilla when implant placement is needed. Therefore, if the outcome is deemed favorable, the use of the modified TSFE would achieve an outcome equivalent to that of the traditional TSFE while introducing less trauma and postoperative discomforts. Separately, whether the bone graft procedure is necessary for the TSFE will also be discussed.Trial registrationThe study has been registered in ClinicalTrials.gov under the identifier number NCT03445039. Registered on 26 February 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2879-x) contains supplementary material, which is available to authorized users.

Efficacy of simultaneous placement of dental implants in osteotome-mediated sinus floor elevation with and without bone augmentation: A systematic review and meta-analysis

“…Out of the 11 studies that were shortlisted for thorough evaluation, two more were excluded[ 24 25 ] due to unmatched parameters. One study[ 26 ] was excluded due to unpublished results, while two studies[ 27 28 ] were not included because they reported the use of lateral approach procedure [ Table 3 ]. Finally, an inclusion of 6 studies[ 29 – 34 ] was possible for meta-analysis [ Supplementary Table 2 ].…”

Radiographic Study of Transcrestal Sinus Floor Elevation Using Osseodensification Technique with Graft Material: A Pilot Study

“…However, Cho et al [19] conclude that adjunctive bone grafting is still indicated for cases requiring more than 2-3 mm of bone augmentation. Nevertheless, the evidence about the necessity of bone graft when residual bone height is below 5 mm is still controversial [22].…”

“…Autogenous bone grafts are considered the gold standard, however, to reduce the morbidity of the donor area, tricalcium phosphate was the first bone substitute to be successfully applied for sinus floor elevation and some studies have registered the improvement in the postoperative period; limited pain and fewer complications were noted [21]. Nevertheless, the necessity of grafting material to maintain the space for new bone formation after elevating the sinus membrane by using the crestal approach remains controversial [22].…”

A importância da elevação do seio maxilar para a instalação de implantes dentários

“…In addition, older patients also exhibited a lower volume, regardless of sex and edentulism. Zhao et al (2018), studied the elevation of the floor of the transalveolar sinus. 120 patients were selected who needed implant placement in the posterior regions of atrophic jaws.…”