Feres Magda, Retamal-Valdes Belén, Mestnik Maria Josefa, de Figueiredo Luciene Cristina, Faveri Marcelo, Duarte Poliana M, Fritoli Aretuza, Faustino Elisangela, Souto Maria Luisa Silveira, de Franco Rodrigues Michelle, Giudicissi Marcela, Nogueira Bárbara Campos Lara, Saraiva Luciana, Romito Giuseppe Alexandre, Pannuti Cláudio Mendes
Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Division of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Trials. 2018 Mar 27;19(1):201. doi: 10.1186/s13063-018-2540-8.
The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) with scaling and root planing (SRP) has shown to be an effective periodontal treatment. However, some essential issues associated with the use of these antibiotics remain unanswered, such as the ideal time of administration during the course of periodontal treatment. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this RCT is to compare the clinical, microbiological and immunological effects of the adjunctive systemic MTZ + AMX administered in different phases of the treatment of severe periodontitis.
Subjects with severe periodontitis (n = 180) are being randomly assigned into three groups (n = 60/group): (i) SRP-only (control group), SRP in combination with 400 mg MTZ + 500 mg AMX, starting (ii) at the first SRP session (active phase group), or (iii) after 3 months of its completion (healing phase group). All volunteers are receiving clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment at baseline and 12 months post-therapy. Nine subgingival biofilm samples are being collected per subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization, and six gingival crevicular fluid samples are being collected and analyzed for the levels of 20 chemokines by multiplex immunoassay. The primary outcome variable is the number of volunteers reaching the clinical endpoint for treatment (≤ 4 sites with probing depth ≥5 mm) at 1 year post-therapy. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using analysis of variance, analysis of covariance and the Chi-square and Tukey tests. Microbiological and immunological analyses will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.
ClinicalTrials.gov , NCT02954393 . Registered on 3 November 2016.
全身应用甲硝唑（MTZ）和阿莫西林（AMX）联合龈下刮治术和根面平整术（SRP）已被证明是一种有效的牙周治疗方法。然而，与使用这些抗生素相关的一些关键问题仍未得到解答，例如在牙周治疗过程中的理想给药时间。尽管这些药物通常在SRP手术的愈合期后开处方，但有生物学合理性支持其与机械治疗联合使用。然而，迄今为止，尚无安慰剂对照的随机临床试验（RCT）直接比较这两种方案。因此，本RCT的目的是比较在重度牙周炎治疗的不同阶段辅助全身应用MTZ + AMX的临床、微生物学和免疫学效果。
患有重度牙周炎的受试者（n = 180）被随机分为三组（每组n = 60）：（i）仅接受SRP（对照组），SRP联合400 mg MTZ + 500 mg AMX，（ii）从第一次SRP治疗开始（急性期组），或（iii）在SRP完成3个月后开始（愈合期组）。所有志愿者在基线、3个月、6个月和12个月时接受临床和微生物学评估，并在基线和治疗后12个月接受免疫学评估。每位受试者采集9份龈下生物膜样本，通过棋盘式DNA-DNA杂交分析40种细菌的数量和比例，并采集6份龈沟液样本，通过多重免疫测定分析20种趋化因子的水平。主要结局变量是治疗后1年达到治疗临床终点（探诊深度≥5 mm的位点≤4个）的志愿者数量。将使用方差分析、协方差分析以及卡方检验和Tukey检验评估组间和随时间变化的临床、微生物学和免疫学参数差异。微生物学和免疫学分析将进行多重比较调整。统计学显著性设定为5%。
ClinicalTrials.gov，NCT02954393。于2016年11月3日注册。
