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A double‐blind, paralleled‐arm, placebo‐controlled and randomized clinical trial of the effectiveness of probiotics as an adjunct in periodontal care

机译:一种双盲,并联臂,安慰剂控制和随机临床试验的益生菌的有效性作为牙周护理中的附属物

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Abstract Aim This study aimed to evaluate the clinical effectiveness of the probiotic Lactobacillus reuteri as an adjunct to non‐surgical periodontal therapy (NSPT). Materials and Methods A double‐blind, paralleled‐arm, placebo‐controlled and randomized clinical trial was conducted. Probiotics L. reuteri or placebo lozenges were randomly prescribed for use twice‐daily for 28?days. Primary outcomes were clinical attachment levels (CAL) and probing pocket depths (PPD). All participants underwent NSPT, and follow‐up clinical assessments were performed at day 90 and day 180. Results The trial response rate was 69.5% (41 out of 59). Among the test and control groups, there were significant intra‐group differences in primary outcomes: CAL (both, p ??.001) and PPD (both, p ??.001); and in secondary outcomes: percentage of sites with ‘bleeding on probing’ (both, p ??.001) and visible plaque (both, p ??.001). There were no statistically significant inter‐group differences in any outcomes at any time points (all, p ??.05) nor in the changes in outcomes (?) with time (all, p ??.05). There was a trend of a greater magnitude of statistical change occurring among the test group compared to the control group. Conclusion The adjunctive use of probiotics with NSPT did not show any additional clinical effectiveness when compared to NSPT alone in the management of periodontitis (ChiCTR‐IOR‐17010526).
机译:摘要目的本研究旨在评估益生菌乳酸杆菌Reuteri作为非手术牙周治疗(NSPT)的辅助临床效果。材料和方法进行双盲,平行臂,安慰剂控制和随机临床试验。益生菌L. Reuteri或安慰剂锭剂被随机订明两次,每天28个?天。主要结果是临床附着水平(CAL)和探测口袋深度(PPD)。所有参与者接受了NSPT,并在第90和第180天进行了后续临床评估。结果试验率为69.5%(59分中为41分)。在试验和对照组中,主要结果存在显着的内部差异:Cal(均,P≤001)和PPD(均,P≤001);在二次结果中:位点的百分比“探测”(探测器上的出血'(两者,p≤001)和可见斑块(两者,p≤001)。任何时间点(全部,p?&Δ05)没有统计学上的统计学间差异与对照组相比,试验组中发生的统计变化发生了更大程度的趋势。结论益生菌与NSPT的辅助使用在与NSPT同时在牙周炎(CHICTR-IOR-17010526)中的NSPT相比时没有显示任何额外的临床效果。

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