Mohanan P V, Mol Lizzy
Toxicology Division, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Poojapura, Thiruvanathapuram 695 012, Kerala, India.
Toxicol Int. 2011 Jul;18(2):155-9. doi: 10.4103/0971-6580.84269.
The ORMO-48 is a new indigenous material for dental applications, developed by the Dental Products Laboratory of our Institute. The aim of the present study was to evaluate the genotoxic effect of an indigenously developed dental material in Swiss albino mice. The genotoxic effect was evaluated by micronucleus and chromosomal aberration tests. Two grams of dental material was extracted in 10.0 ml of physiological saline at 70°C for 24 h. The extract was cooled to room temperature and was used for the experiment. The experimental designed had three groups each (six mice in each group) for micronucleus and chromosomal aberration tests. The first, second, and third groups were given a single exposure of physiological saline alone (control), dental material's extract (test), and cyclophosphamide (positive control) respectively for micronucleus and chromosomal aberration tests. The result of the study indicated that, the percentage of micronucleated PCE (polychromatic erythrocytes) and NCE (normochromatic erythrocytes) induced by the dental material (extract) treated group was well comparable with control group, whereas the positive control induced significantly high (P < 0.001) micronucleated PCE when compared to control. The PCE and NCE ratio of the dental material extract treated group was similar to that of control group. The chromosomal anomalies such as chromatid/chromosomal breaks, centric rings, exchanges, dicentric, and acentric fragments were evaluated. The result showed that the anomalies of the dental material extract treated group were similar to control group, however, significant anomalies were observed in the cyclophosphamide treated group. Hence, the present study concluded that the indigenously developed biocompatible dental material, ORMO-48 is non genotoxic at our laboratory conditions.
ORMO - 48是一种用于牙科应用的新型国产材料，由我们研究所的牙科产品实验室研发。本研究的目的是评估一种国产牙科材料对瑞士白化小鼠的遗传毒性作用。通过微核试验和染色体畸变试验评估遗传毒性作用。将2克牙科材料在70°C下于10.0毫升生理盐水中提取24小时。提取物冷却至室温后用于实验。微核试验和染色体畸变试验的实验设计均有三组（每组六只小鼠）。第一组、第二组和第三组在微核试验和染色体畸变试验中分别单次给予生理盐水（对照）、牙科材料提取物（试验）和环磷酰胺（阳性对照）。研究结果表明，牙科材料（提取物）处理组诱导的微核多染红细胞（PCE）和正常红细胞（NCE）的百分比与对照组相当，而与对照组相比，阳性对照诱导的微核多染红细胞显著升高（P < 0.001）。牙科材料提取物处理组的PCE与NCE比率与对照组相似。评估了染色单体/染色体断裂、着丝粒环、交换、双着丝粒和无着丝粒片段等染色体异常情况。结果显示，牙科材料提取物处理组的异常情况与对照组相似，然而，在环磷酰胺处理组中观察到了显著的异常。因此，本研究得出结论，在我们的实验室条件下，国产生物相容性牙科材料ORMO - 48无遗传毒性。
