Descriptive retrospective study analyzing relevant factors related to dental implant failure

L. Castellanos-Cosano, A. Rodríguez-Pérez, S. Spinato, M. Wainwright, G. Machuca-Portillo, M. Serrera-Figallo, D. Torres-Lagares
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引用次数: 26

Abstract

Background The objective of this retrospective descriptive study was to analyze the characteristics of incident reports provided by dentists while using a specific brand of dental implants. Material and Methods The study was carried out in collaboration with Oxtein Iberia S.L.®, with the company providing access to the incident database in order to evaluate the characteristics of incidents from January 2014 to December 2017 (a total of 917 over four years). The data sheet recorded different variables during each of the stages of implant treatment, from initial implant placement to subsequent prosthetic rehabilitation. These variables included age, sex, systemic pathologies, smoking habits, bone quality, implant type, prosthesis type, and type of load applied, among others. SPSS Statistics was used to perform statistical analysis of the qualitative variables (univariate logistic regressions, χ2 test, Haberman's adjusted standardized residuals). Results The total study sample consisted of 44,415 implants shipped from Oxtein® warehouses on the dates indicated, of which 917 implants (2.1%) were flagged due to reports of lack of primary stability, failed osseointegration, or implant failure within one year of placement. When analyzing incident reports, it was observed that 61.6% of incidents occurred in male patients, compared to 38.4% in female patients. The average age of patients in the reported cases was 56.12 ± 12.15 years. A statistically significant correlation was discovered between incidents of implant failure and tobacco use, diabetes, heart disease, poor oral hygiene, previous infection, poor bone quality, and bruxism (p < 0.05). A (statistically significant) higher rate of incidents was also observed in tapered, internal connection, Grade IV titanium, narrow, and short implants. Conclusions Analysis of these implants reveals a higher rate of complication in short, tapered, internal connection and narrow-diameter implants. These data can help and encourage clinicians to use the utmost surgical precautions when placing these implants. Key words:Pharmacovigilance, Dental implant, Dental implant failure.
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描述性回顾性研究分析与种植体失败相关的因素
本回顾性描述性研究的目的是分析牙医在使用特定品牌种植体时提供的事件报告的特征。该研究是与Oxtein Iberia S.L.®合作开展的,该公司提供事件数据库的访问权限,以评估2014年1月至2017年12月(四年共917起)的事件特征。数据表记录了种植体治疗的每个阶段的不同变量,从最初的种植体放置到随后的假肢康复。这些变量包括年龄、性别、全身病理、吸烟习惯、骨质量、种植体类型、假体类型和施加的载荷类型等。采用SPSS统计软件对定性变量进行统计分析(单变量logistic回归、χ2检验、Haberman校正标准化残差)。结果研究样本包括从Oxtein®仓库发货的44,415个种植体,其中917个(2.1%)种植体由于缺乏初级稳定性、骨整合失败或种植体在放置一年内失效而被标记。在分析事件报告时,我们发现61.6%的事件发生在男性患者中,而女性患者的发生率为38.4%。报告病例患者平均年龄56.12±12.15岁。种植体失败与吸烟、糖尿病、心脏病、口腔卫生不良、既往感染、骨质量差、磨牙有统计学意义的相关性(p < 0.05)。锥形、内连接、IV级钛、窄的和短的种植体也观察到较高的发生率(有统计学意义)。结论对这些种植体的分析表明,短、锥形、内连接和窄直径种植体的并发症发生率较高。这些数据可以帮助和鼓励临床医生在放置这些植入物时使用最大的手术预防措施。关键词:药物警戒;种植体;种植体失败
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