Amaral Ana Luisa, Lund Bodil, Andrade Sérgio Araújo
Faculty of Dentistry, University of Itaúna (UIT), Itaúna, MG, Brazil.
Research Center on Biological Chemistry (NQBio), Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil.
Evid Based Dent. 2024 Dec;25(4):180-181. doi: 10.1038/s41432-024-01027-1. Epub 2024 Jun 12.
Prospective, parallel, randomized, double-blind, clinical trial.
Participants were at least 30 years old, who were systemically healthy, with stages III-IV, grades B-C periodontitis.
Of the 50 eligible individuals for the study, 40 were divided into 2 equal groups. The test group received doses of 500 mg of metronidazole, while the control group received a placebo, both administered three times a day for 7 days, commencing immediately after periodontal surgery. All patients were followed up at 3-, 6-, 9-, and 12-months post-surgery. The study utilized probing depth, clinical attachment level, bleeding on probing, and plaque index as parameters for determining the outcomes at each assessment. Microbiological samples were collected for the detection and quantification of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and Tannerella forsythia DNA. In order to analyze quantitative variables in a comparison between the test and control groups, Student's t-tests or Mann-Whitney U tests were utilized. For categorical results, chi-square or Fisher tests were employed. For both probing depth and clinical attachment level, repeated measures ANOVA was used. The statistical significance level was set at p ≤ 0.05.
The study found statistically significant differences for probing depth (mean difference, MD = 0.31 mm, 95% confidence interval, CI [0.13; 0.49]; p = 0.001) and clinical attachment level (MD = 0.64 mm, 95% CI [0.02; 1.27]; p = 0.044) only 3 months after surgery, with a reduction observed in the test group. However, despite being statistically significant, these results lack clinical relevance.
Although the study found statistically significant results for clinical attachment level (MD = 0.66 mm, 95% CI [0.01; 1.31]; p = 0.045) and probing depth (MD = 0.28 mm, 95% CI [0.09; 0.46]; p = 0.004), these findings do not represent clinically significant gains. Therefore, no evidence was demonstrated to support the use of systemic metronidazole as adjunctive therapy to periodontal surgery.
前瞻性、平行、随机、双盲临床试验。
参与者年龄至少30岁，全身健康，患有III - IV期、B - C级牙周炎。
在50名符合研究条件的个体中，40人被平均分为2组。试验组接受500毫克甲硝唑剂量，而对照组接受安慰剂，两者均每天服用3次，持续7天，在牙周手术后立即开始。所有患者在术后3、6、9和12个月进行随访。该研究采用探诊深度、临床附着水平、探诊出血和菌斑指数作为每次评估时确定结果的参数。收集微生物样本用于检测和定量牙龈卟啉单胞菌、伴放线聚集杆菌和福赛坦纳菌的DNA。为了分析试验组和对照组之间比较中的定量变量，使用了学生t检验或曼 - 惠特尼U检验。对于分类结果，采用卡方检验或费舍尔检验。对于探诊深度和临床附着水平，使用重复测量方差分析。统计学显著性水平设定为p≤0.05。
该研究发现仅在术后3个月时，探诊深度（平均差异，MD = 0.31毫米，95%置信区间，CI [0.13; 0.49]; p = 0.001）和临床附着水平（MD = 0.64毫米，95% CI [0.02; 1.27]; p = 0.044）存在统计学显著差异，试验组有降低。然而，尽管具有统计学显著性，但这些结果缺乏临床相关性。
尽管该研究发现临床附着水平（MD = 0.66毫米，95% CI [0.01; 1.31]; p = 0.045）和探诊深度（MD = 0.28毫米，95% CI [0.09; 0.46]; p = 0.004）具有统计学显著结果，但这些发现并不代表临床上的显著获益。因此，没有证据表明支持使用全身甲硝唑作为牙周手术的辅助治疗。
