Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults.
Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults.
复制标题
非空洞龋齿病变的视觉评分和临床试验效率，在龋齿活跃的成人中测试木糖醇。
DOI：
10.1111/cdoe.12082
复制
发表时间：
2014
影响因子：
2.3
通讯作者：
X-ACTTrialCollaborativeGroup
中科院分区：
文献类型：
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作者：
Brown,JohnP;Amaechi,BennettT;Bader,JamesD;Gilbert,GreggH;Makhija,SoniaK;Lozano-Pineda,Juanita;Leo,MichaelC;Chen,Chuhe;Vollmer,WilliamM;X-ACTTrialCollaborativeGroup
目的为了更好地了解木糖醇在成人龋齿预防中的有效性，并尝试提高临床试验效率。方法作为木糖醇成人龋齿试验 (X-ACT) 的一部分，对正在经历该疾病的受试者的非空洞和空洞龋齿病变进行评估。该试验测试了每天 5 克木糖醇的有效性，与三氯蔗糖安慰剂相比，每天将 5 颗 1 克含片溶解在口中服用。为了寻求试验效率，本次分析从 691 名受试者中随机选择了 538 名年龄在 21-80 岁之间且拥有四次牙科检查完整数据的受试者，参加在三个地点进行的为期 3 年的试验。使用 kappa 统计数据对试验前和试验期间可接受的检查者间和检查者内部的可靠性进行了量化。 结果 在 12、24 和 33 个月的三个累积期间，冠状和牙根表面从健全到龋齿的平均年化非空洞和空洞病变转变评分，木糖醇优于安慰剂，但这些临床和统计上不显着的差异随着时间的推移而幅度下降。将目前的评估限制在那些基线终生龋齿经历较高的受试者中，显示出可能但不一致的益处。结论：当评估非空洞和空洞病变时，木糖醇对暴露于足够氟化物的成年人的龋齿没有明确的和临床相关的预防作用。这与评估空洞病变的 X-ACT 试验结果一致。在这项针对患有龋齿的成人的全面、安慰剂对照、多中心、随机、双盲临床试验中包括非空化病变评估，并未实现更高的试验效率或证明木糖醇的实际益处。试验注册：ClinicalTrials.Gov NCT00393055。
ObjectivesTo better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency.MethodsAs part of the Xylitol for Adult Caries Trial (X‐ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21–80, with complete data for four dental examinations, were selected from the 691 randomized into the 3‐year trial, conducted at three sites. Acceptable inter‐ and intra‐examiner reliability before and during the trial was quantified using the kappa statistic.ResultsThe mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit.ConclusionsThere was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X‐ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full‐scale, placebo‐controlled, multisite, randomized, double‐blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055.