玻璃离子 ART 水门汀和氟释放树脂水门汀预防窝沟龋的效果——一项随机临床试验的结果。
Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial.
机构信息
Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Hong Kong, SAR, China.
出版信息
BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.
BACKGROUND
The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China (ClinicalTrials.gov NCT01829334).
METHODS
After obtaining ethical approval, healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study. Included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth. Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods. Fissure status of the molars in each group was evaluated every 6 months. Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report. Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere.
RESULTS
At baseline, a total of 280 children (383 molars) with mean age 7.8 years were involved for the two sealant groups. After 24 months, 261 children (357 molars) were followed. Proportions of molars with dentine caries were 7.3% and 3.9% in the ART sealant and fluoride-releasing resin sealant groups, respectively (chi-square test, p = 0.171). Life-table survival analysis showed that sealant retention (full and partial) rate over 24 months for the resin sealant (73%) was significantly higher than that (50%) for the ART sealant (p < 0.001). Molar survival (no development of dentine caries) rates in the ART sealant (93%) and fluoride-releasing resin sealant (96%) groups were not significantly different (p = 0.169). Multilevel logistic regression (GEE modeling) accounting for the effects of data clustering and confounding factors confirmed this finding.
CONCLUSIONS
Though the retention of fluoride-releasing resin sealant was better than that of the ART sealant, their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months. ART sealants could be a good alternative when and where resources for resin sealant placement are not readily available.
背景
在中国南方进行的一项随机临床试验（ClinicalTrials.gov NCT01829334）比较了 ART 密封剂和释放氟树脂密封剂在预防恒磨牙窝沟龋中的相对性能。
方法
获得伦理批准后，招募了具有完整但深的咬合面窝沟或仅有初期龋的健康学龄儿童的恒第一磨牙进行研究。纳入的磨牙按每口牙的左右牙单位随机分配到四个平行研究组之一。其中两组采用 ART 或释放氟树脂密封剂放置方法，另外两组采用局部氟化物应用方法。每 6 个月评估每组磨牙的窝沟状况。本报告比较了在 24 个月内使用两种密封剂的两组中牙本质龋的发展和密封剂保留情况。36 个月内所有四组的成本效益结果将在其他地方报告。
结果
在基线时，共有 280 名儿童（383 颗磨牙），平均年龄为 7.8 岁，参与了两组密封剂的研究。24 个月后，261 名儿童（357 颗磨牙）被随访。ART 密封剂组和释放氟树脂密封剂组的牙本质龋牙比例分别为 7.3%和 3.9%（卡方检验，p=0.171）。寿命表生存分析显示，树脂密封剂（完整和部分）保留率在 24 个月时（73%）明显高于 ART 密封剂（50%）（p<0.001）。ART 密封剂（93%）和释放氟树脂密封剂（96%）组的磨牙存活率（无牙本质龋发展）无显著差异（p=0.169）。考虑到数据聚类和混杂因素影响的多水平逻辑回归（GEE 建模）证实了这一发现。
结论
虽然释放氟树脂密封剂的保留效果优于 ART 密封剂，但在 24 个月内，它们预防恒磨牙窝沟龋的效果并无显著差异。当释放氟树脂密封剂放置资源不可用时，ART 密封剂可以作为一种很好的替代方法。
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