浓缩生长因子在上颌窦侧壁开窗窦底提升即刻种植中的成骨效果:单中心、随机对照临床试验方案

发布时间：2018-11-02 15:27

【摘要】：背景:上颌窦侧壁开窗窦底提升是克服萎缩上颌后牙区骨量不足最有效的方法,且骨移植被认为是上颌窦提升成功的先决条件。富血小板血浆和血小板纤维蛋白已被用于加速新骨形成、再生和修复,但是浓缩生长因子对新骨形成的研究并不深入。目的:探讨浓缩生长因子在上颌窦侧壁开窗窦底提升即刻种植中对骨缺损区的修复和成骨效果的影响。方法:随机双盲对照试验将在西南医科大学附属口腔医院完成。40例上颌磨牙缺失、上颌后牙区剩余骨高度为2-5 mm的患者被纳入研究,并随机分为浓缩生长因子组(n=20)和对照组(n=20),分别于上颌窦侧壁开窗窦底提升即刻,将浓缩生长因子+羟基磷灰石+自体骨或羟基磷灰石+自体骨种植体植于骨缺损区。于种植后1,3和6个月行X射线平片检查,判断种植区骨组织再生、骨修复效果,并以优良率作为评估标准;应用锥形束CT测量上颌窦骨缺损填充区骨皮质厚度,以反映骨质密度。研究方案已取得西南医科大学附属口腔医院伦理委员会的书面批准,且符合世界医学会制订的《赫尔辛基宣言》,并已在北美临床试验注册中心注册(NCT03046173)。患者均签署知情同意书。结果与结论:研究已于2016年完成。获得的研究结果:X射线平片显示,随访3和6个月时浓缩生长因子组种植体引导周围骨缺损中的骨组织再生效果较好,优于对照组(P0.01),且6个月时优于3个月时。随访1,3,6个月时浓缩生长因子组骨种植区骨质密度明显高于对照组(P0.01)。说明浓缩生长因子可促进上颌窦侧壁开窗窦底提升即刻种植体种植后的新骨形成,加快骨结合。
[Abstract]:Background: maxillary sinus lateral wall fenestration is the most effective method to overcome the shortage of bone mass in atrophic maxillary posterior teeth and bone transplantation is considered to be a prerequisite for the success of maxillary sinus elevation. Platelet-rich plasma and platelet fibrin have been used to accelerate the formation, regeneration and repair of new bone. Objective: to investigate the effect of concentrated growth factor on the repair of bone defect and osteogenesis during immediate implantation of fenestration in lateral wall of maxillary sinus. Methods: a randomized double-blind controlled trial was carried out in the affiliated Stomatology Hospital of Southwest Medical University. Forty patients with maxillary molar missing and residual bone height of 2-5 mm in the maxillary posterior region were included in the study. They were randomly divided into two groups: the concentrated growth factor group (nm20) and the control group (nm20). The autogenous bone or hydroxyapatite autologous bone implants of concentrated growth factor hydroxyapatite (HCF) were implanted in the bone defect area immediately after the lateral wall of maxillary sinus was raised by fenestration. X-ray plain radiography was performed 1 month and 6 months after implantation to judge the regeneration of bone tissue and the effect of bone repair. The excellent and good rate was used as the evaluation criterion. The thickness of bone cortex in bone defect filled area of maxillary sinus was measured by conical bundle CT to reflect bone density. The research program has been approved in writing by the Ethics Committee of Stomatology Hospital affiliated to Southwest Medical University and is in accordance with the Helsinki Declaration formulated by the World Medical Association and has been registered with the North American Center for Clinical Trials (NCT03046173). All patients signed informed consent. Results & conclusion: the study was completed in 2016. Results: X-ray plain films showed that the regeneration of bone tissue in the implant guided by implants was better than that in the control group (P0.01), and at 6 months, it was better than that at 3 months after the implantation in the concentrated growth factor group (P 0.01), and at 6 months it was better than that in the control group (P0.01), and at 6 months it was better than at 3 months. The bone density was significantly higher in the BGF group than in the control group (P0.01). The results showed that the concentration of growth factor could promote the formation of new bone after immediate implant implantation and accelerate the osseous bonding at the fenestration of the lateral wall of maxillary sinus.
【作者单位】：德阳市口腔医院;西南医科大学附属口腔医院;
【基金】：四川省科技计划项目(LY-51)~~
【分类号】：R783.6

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