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

      research-article
      , ,
      Trials
      BioMed Central
      Dental implants, Transalveolar sinus floor elevation, Clinical evaluation, Bone grafting

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          Abstract

          Background

          Implant 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/design

          One 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.

          Discussion

          The 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 registration

          The study has been registered in ClinicalTrials.gov under the identifier number NCT03445039. Registered on 26 February 2018.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2879-x) contains supplementary material, which is available to authorized users.

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          Most cited references20

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          Maxillary and sinus implant reconstructions.

          H. Tatum (1986)
          The root and sinus series of the Omnii system have been used extensively since 1981. They are very versatile in their ability to be used within edentulous areas of the maxilla. Their design attempts to maximize the use of the available bone, and placement techniques allow the manipulation of bone to form sockets in otherwise deficient areas of bone. The root implants can be used as free-standing implants or as multiple abutments. The sinus implant is always used as an abutment. It may be used in conjunction with other implants or with natural abutments. Maxillary implants are not loaded until a 6-month healing time has elapsed following placement. An understanding of the different qualities of bone found in the maxilla is important to achieving the successful loading of these implants. Different times are required to allow physiologic loading in different qualities of maxillary bone. Restorative treatment is normally done with fixed bridge work, and the use of any type of stress breaker attachments is not recommended.
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            A new concept in maxillary implant surgery: the osteotome technique.

            This article reviews the limitations of drilling into soft bone to place endosseous implants. Differences among bone types and the anatomy of the maxilla are described. The osteotome technique, which is a new method of placing implants into maxillary bone without drilling, and the rationale for two other procedures, the osteotome sinus floor elevation and the ridge expansion osteotomy, are detailed. How osteotomes conserve osseous tissue and may improve bone density around the implant is also discussed. A pilot study that shows excellent results with several types of press-fit implants using the osteotome technique is provided. The author concludes that the osteotome technique is superior to drilling for many applications in soft maxillary bone. Furthermore, the osteotome technique allows more implants to be inserted in a greater variety of sites during a routine office procedure.
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              A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique.

              The objectives of this systematic review were to assess the survival rate of implants placed in sites with transalveolar sinus floor elevation. An electronic search was conducted to identify prospective and retrospective cohort studies on transalveolar sinus floor elevation, with a mean follow-up time of at least 1 year after functional loading. Failure and complication rates were analyzed using random-effects Poisson regression models to obtain summary estimates/ year proportions. The search provided 849 titles. Full-text analysis was performed for 176 articles, resulting in 19 studies that met the inclusion criteria. Meta-analysis of these studies indicated an estimated annual failure rate of 2.48% (95% confidence interval (95% CI): 1.37-4.49%) translating to an estimated survival rate of 92.8% (95% CI): 87.4-96.0%) for implants placed in transalveolarly augmented sinuses, after 3 years in function. Furthermore, subject-based analysis revealed an estimated annual failure of 3.71% (95% CI: 1.21-11.38%), translating to 10.5% (95% CI: 3.6-28.9%) of the subjects experiencing implant loss over 3 years. Survival rates of implants placed in transalveolar sinus floor augmentation sites are comparable to those in non-augmented sites. This technique is predictable with a low incidence of complications during and post-operatively.
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                Author and article information

                Contributors
                zhaoxu_@hotmail.com
                godwin060407@163.com
                +86 010 13801376503 , dentistliufeng@126.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                14 September 2018
                14 September 2018
                2018
                : 19
                : 489
                Affiliations
                GRID grid.479981.a, Peking University Hospital of Stomatology First Clinical Division, ; 37A Xishiku Street, Xicheng District, Beijing, 100034 China
                Article
                2879
                10.1186/s13063-018-2879-x
                6137932
                30217227
                4b0af5d6-7bcd-43c8-9009-16387e8e9809
                © The Author(s). 2018

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 21 March 2018
                : 25 August 2018
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                dental implants,transalveolar sinus floor elevation,clinical evaluation,bone grafting
                Medicine
                dental implants, transalveolar sinus floor elevation, clinical evaluation, bone grafting

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