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A double‐masked Randomized Clinical Trial ( RCT RCT ) comparing four periodontitis treatment strategies: 5‐year clinical results

机译:双掩蔽随机临床试验(RCT RCT)比较四个牙周炎治疗策略:5年的临床结果

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Abstract Aim To test the hypothesis of no difference in the 5‐year clinical outcome of therapy between groups of patients treated with conventional over‐weeks scaling and root planing or same‐day full‐mouth‐disinfection, with or without adjunctive metronidazole (MTZ). Materials and Methods Following a three‐month oral hygiene phase, 184 periodontitis patients were randomly allocated to one of four treatment regimens (1) full‐mouth disinfection (FDIS)+ MTZ, (2) FDIS +placebo, (3) scaling and root planing+ MTZ and (4) scaling and root planing+placebo. Following active treatment, patients received biannual maintenance; 161 patients completed the five‐year follow‐up maintenance and examination, where clinical attachment level (CAL), probing pocket depth (PPD), presence of plaque and bleeding were registered. Results Metronidazole increased the highest CAL recording statistically insignificantly by an average of 0.17?mm while FDIS decreased it by an average of 0.12?mm. The corresponding values for the highest PPD were 0.00 and 0.05?mm, respectively. Conclusion While single‐level analyses showed statistically significant differences, they could not be confirmed with more appropriate analyses and were too small to recommend MTZ, with its risk of patient side effects and environmental consequences, for the treatment of patients with severe periodontitis.
机译:摘要旨在测试常规周缩放和根部缩放或同日全口消毒,有或没有辅助甲硝唑(MTZ)治疗患者患者患者患者患者患者患者患者的5年临床结果假设的假设。 。将184名牙周炎患者随机分配给四个月的口服卫生阶段后,将184名牙周炎患者进行一次治疗方案(1)全口消毒(FDIS)+ MTZ,(2)FDIS +安慰剂,(3)缩放和根刨平+ MTZ和(4)缩放和根刨+安慰剂。在积极治疗后,患者接受了两年的维护; 161例患者完成了五年的后续维护和检查,其中临床附着水平(CAL),探测口袋深度(PPD),斑块的存在和出血。结果甲硝唑统计学上的最高速度均匀,平均值为0.17Ωmm,而FDI平均降低0.12Ωmm。最高PPD的相应值分别为0.00和0.05Ωmm。结论单层分析显示出统计学上显着的差异,无法通过更合适的分析确认,并且太小而无法推荐MTZ,其患者副作用和环境后果的风险,用于治疗严重牙周炎的患者。

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