PDF(Pubmed)
Abstract：
Introduction Guided tissue regeneration (GTR) is integral to periodontal therapy, facilitating the repair of osseous defects. Due to the widespread use of bovine pericardium (BP) in GTR, a thorough investigation into its genotoxicity is essential for patient safety and treatment efficacy. This study aimed to evaluate the genotoxic effects of local BP in GTR for periodontal osseous defects. Materials and methods The Bacterial Reverse Mutation Assay (Ames test) was used to assess the genotoxic potential of local BP. An exogenous metabolic activation system was employed to evaluate the direct effects of the material on bacterial cells. Results The study investigated the mutagenic effects of local BP across multiple strains of Salmonella typhimurium, utilizing concentrations ranging from 0.3125 mg/plate to 5 mg/plate. While some variability was observed in revertant counts, the generally low SDs suggest a consistent response to the test substance. The maximum revertant count for each strain did not significantly exceed the mean values, indicating the absence of notable outliers or exceptionally high revertant counts at any specific concentration. Based on the data and toxicity assessment criteria, there is insufficient evidence to suggest that the experimental material induces genotoxic effects in the tested bacterial strains under the provided experimental conditions. Conclusion This study assessed the mutagenic potential of local BP membranes used in GTR with the Ames test. Results showed no evidence of mutagenicity, as revertant counts did not exceed twice the negative control in all bacterial strains with exogenous metabolic activation. This suggests that bovine pericardium membranes are safe for medical use under the test conditions. The study highlights the biocompatibility and non-mutagenic nature of BP membranes in GTR for periodontal therapy.
摘要：
导言引导组织再生（GTR）是牙周治疗不可或缺的，促进骨缺损的修复。由于牛心包（BP）在GTR中的广泛使用，对其遗传毒性的彻底调查对于患者安全和治疗效果至关重要.本研究旨在评估GTR中局部BP对牙周骨缺损的遗传毒性作用。材料和方法细菌反向突变测定(Ames试验)用于评估局部BP的基因毒性潜力。使用外源代谢活化系统来评估材料对细菌细胞的直接影响。结果本研究调查了鼠伤寒沙门氏菌多株局部BP的诱变效应。利用浓度范围从0.3125毫克/板5毫克/板。虽然在回复体计数中观察到一些变异性，一般较低的SD表明对测试物质的反应一致。每个菌株的最大回复体计数没有明显超过平均值，表明在任何特定浓度下都没有明显的异常值或异常高的回复体计数。根据数据和毒性评估标准，没有足够的证据表明实验材料在提供的实验条件下在测试的细菌菌株中诱导基因毒性作用。结论本研究通过Ames试验评估了GTR中使用的局部BP膜的诱变潜力。结果显示没有诱变的证据，因为在所有具有外源代谢激活的细菌菌株中，回复体计数不超过阴性对照的两倍。这表明牛心包膜在测试条件下对于医疗用途是安全的。该研究强调了GTR中BP膜用于牙周治疗的生物相容性和非诱变性。
