初步热暴露复合材料治疗龋齿的临床依据:随机临床试验

U. A. Shipieva, A. Adamchik, A. Gushchin, V. N. Samhaev, K. D. Kirsh, M. A. Adamchik, N. O. Risovannaya
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引用次数: 0

摘要

背景。与传统的修复材料如汞合金相比,聚合物复合材料具有良好的美学特性和显著的物理化学性能。但临床常用的含双甲基丙烯酸酯基团的复合材料在聚合反应时,总会出现不同程度的体积收缩(2.7%~7.1%)。由此产生的应力会导致粘连失败等不良临床后果,如牙釉质破坏、复合材料微开裂、复合材料与牙腔壁之间形成微渗漏,导致龋复发和术后敏感,从而影响修复的远期效果。因此,研究预热对复合材料修复的影响对其临床应用具有重要意义。目标。通过改善复合修复体的理化性质,提高对龋病患者的治疗效果。一项随机临床试验招募了180名年龄在18至45岁之间,被诊断为I级牙本质龋齿的患者,根据Black (ICD K02.1)。本研究在俄罗斯库班国立医科大学牙科诊所进行,对180例磨牙牙本质龋进行了复合修复治疗。患者随机分为两组:对照组90例,主组90例。对照组和主要组依次分为三个亚组,根据所使用的复合材料- Estelite Sigma Quick (Tokuyama Dental,日本),Filtek Bulk Fill Posterior Restorative (3M Espe,美国)和DentLight (VladMiVa,俄罗斯)。每个亚组由30例患者组成。对照组采用“室温”下复合材料填充的经典方法。在主组中,使用复合加热调节器“Ena Heat”(Micerium, Italy)将复合材料加热到55°C,然后将材料适应于形成的腔中进行随后的光聚合。在临床研究中,复合修复体的质量在治疗后立即和6、12、18、24个月后使用改良的Ryge标准进行评估。采用GraphPad软件(GraphPad Software, USA)的GraphPadPrism 9程序对所得数据进行单因素方差分析。临床研究持续时间为24个月。该研究显示,对照组复合修复体的边际拟合质量(根据Ryge评分)下降了20.1% (p = 0.0001),主组下降了5.7% (p = 0.0328),具有统计学意义。同时,主组复合材料各亚组的Ryge评分变化无统计学意义(pF = 0.9480, pE = 0.1837, pD = 0.2529)。研究结果表明,在密封和随后的光聚合之前,使用专用炉对复合材料进行预热的最佳时间算法为7秒。该研究表明,与在“室温”下处理复合材料的经典方法相比,所提出的处理加热复合材料的算法在处理后长期的边缘拟合质量方面具有统计学上显著的积极影响。
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Clinical Justification for Preliminary Thermal Exposure to Composite in the Treatment of Caries: Randomized Clinical Trial
Background. Polymer composites have good aesthetic characteristics and pronounced physicochemical properties, as compared to traditional restorative materials such as amalgam. However, the polymerization reaction of composite material containing bismethacrylate group commonly used in clinical practice is always accompanied by a different degree of volumetric shrinkage (2.7%~7.1%). The resulting stress can lead to adhesion failure and some other unfavorable clinical consequences, such as enamel destruction, microcracking of composite material and formation of microleakage between composite and tooth cavity wall, which can result in recurrent caries and postoperative sensitivity, thereby affecting the long-term effect of restoration. Therefore, studying the effect of preheating on composite restoration is important for its clinical application. Objective. To improve the effectiveness of treatment of patients with dental caries by improving the physicochemical properties of composite restorations.Methods. A randomized clinical trial enrolled 180 patients aged 18 to 45 years, diagnosed with dentin caries class I, according to Black (K02.1 in ICD). The study was conducted in the Dental Clinic of Kuban State Medical University, Russia. 180 composite restorations were performed in the treatment of dentin caries of molars. Patients were randomized into 2 groups): the control group — 90 patients and the main group — 90 patients. The control and main groups, in turn, were divided into three subgroups, depending on the composite used — Estelite Sigma Quick (Tokuyama Dental, Japan), Filtek Bulk Fill Posterior Restorative (3M Espe, USA) and DentLight (VladMiVa, Russia). Each subgroup consisted of 30 patients. In the control group, the classical method of filling with a composite material at “room temperature” was applied. In the main group, a composite heating conditioner “Ena Heat” (Micerium, Italy) was used to heat the composite to 55 °C before adapting the material in the formed cavity with subsequent photopolymerization. The quality of composite restorations within the clinical study was evaluated using the modified Ryge criterion immediately after treatment and after 6, 12, 18, 24 months. Statistical processing of the obtained data was carried out by means of one-factor analysis of variance using the GraphPadPrism 9 program (GraphPad Software, USA).Results. The duration of the clinical study comprised 24 months. The study revealed a statistically significant decrease in the quality of marginal fit of composite restorations (according to the Ryge score) by 20.1% (p = 0.0001) in the control group and by 5.7% (p = 0.0328) in the main group.  At the same time, no statistically significant changes in Ryge scores were reported in the subgroups of composite materials of the main group (pF = 0.9480, pE = 0.1837, pD = 0.2529). As a result of the study, an optimal time algorithm (7 seconds) for using a special furnace for preheating the composite before sealing with subsequent photopolymerization was obtained.Conclusion. The study revealed a statistically significant positive effect of the proposed algorithm for working with a heated composite on the quality of marginal fit in the long term after treatment in comparison with the classical method of working with a composite at “room temperature”.
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