The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial

Trials

Poliana M. Duarte¹  Luciene Cristina de Figueiredo¹  Magda Feres¹  Aretuza Fritoli¹  Maria Josefa Mestnik¹  Marcelo Faveri¹  Elisangela Faustino¹  Belén Retamal-Valdes¹  Marcela Giudicissi²  Bárbara Campos Lara Nogueira²  Cláudio Mendes Pannuti²  Giuseppe Alexandre Romito²  Luciana Saraiva²  Maria Luisa Silveira Souto²  Michelle de Franco Rodrigues² 

[1] Department of Periodontology, Dental Research Division, Guarulhos University;Division of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo;

关键词: Periodontitis;    Periodontal Disease;    Metronidazole;    Amoxicillin;    Scaling and Root Planing;    Treatment;   

DOI  :  10.1186/s13063-018-2540-8

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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%. Trial registration ClinicalTrials.gov, NCT02954393. Registered on 3 November 2016.

【 授权许可】

Unknown