Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Mar 27;19(1):201.
doi: 10.1186/s13063-018-2540-8.

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

Magda Feres  1 , Belén Retamal-Valdes  2 , Maria Josefa Mestnik  2 , Luciene Cristina de Figueiredo  2 , Marcelo Faveri  2 , Poliana M Duarte  2 , Aretuza Fritoli  2 , Elisangela Faustino  2 , Maria Luisa Silveira Souto  3 , Michelle de Franco Rodrigues  3 , Marcela Giudicissi  3 , Bárbara Campos Lara Nogueira  3 , Luciana Saraiva  3 , Giuseppe Alexandre Romito  3 , Cláudio Mendes Pannuti  3
Affiliations

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

Magda Feres et al. Trials. .

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.

Keywords: Amoxicillin; Antibiotics; Metronidazole; Periodontal Disease; Periodontitis; Scaling and Root Planing; Treatment.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The authors declare that the Guarulhos University Clinical Research Ethics Committee (CAAE: 32.465.714.4.1001.5506) and University of São Paulo (SP) Ethics Committee (CAAE: 32.465.714.4.2001.0075) approved the study protocol. In addition, we declare that all participants have signed the informed consent term and approved their participation in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare no potential competing interests with respect to the authorship and/or publication of this article.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Experimental design of the M.O.M.E.N.T. study. CLIN: clinical assessment; MICRO: microbiological assessment; IMMUNO: immunological assessment; OHI: oral hygiene instruction; SRP: scaling and root planing; MTZ: metronidazole (400 mg/thrice daily); AMX: amoxicillin (500 mg/TID); PMT: periodontal maintenance therapy
See this image and copyright information in PMC

References

    1. Marsh PD, Moter A, Devine DA. Dental plaque biofilms: communities, conflict and control. Periodontol. 2011;55(1):16–35. doi: 10.1111/j.1600-0757.2009.00339.x. - DOI - PubMed
    1. Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol. 2014;64(1):57–80. doi: 10.1111/prd.12002. - DOI - PMC - PubMed
    1. Drisko CL. Periodontal debridement: still the treatment of choice. J Evid Based Dent Pract. 2014;14(Suppl):33–41.e1. doi: 10.1016/j.jebdp.2014.02.007. - DOI - PubMed
    1. Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol. 2015;67(1):131–186. doi: 10.1111/prd.12075. - DOI - PubMed
    1. Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis. J Periodontol. 2012;83(10):1257–1269. doi: 10.1902/jop.2012.110625. - DOI - PubMed

Publication types

MeSH terms

Associated data