The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial
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 a...
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2018-03-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-018-2540-8 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Magda Feres Belén Retamal-Valdes Maria Josefa Mestnik Luciene Cristina de Figueiredo Marcelo Faveri Poliana M. Duarte Aretuza Fritoli Elisangela Faustino Maria Luisa Silveira Souto Michelle de Franco Rodrigues Marcela Giudicissi Bárbara Campos Lara Nogueira Luciana Saraiva Giuseppe Alexandre Romito Cláudio Mendes Pannuti |
spellingShingle |
Magda Feres Belén Retamal-Valdes Maria Josefa Mestnik Luciene Cristina de Figueiredo Marcelo Faveri Poliana M. Duarte Aretuza Fritoli Elisangela Faustino Maria Luisa Silveira Souto Michelle de Franco Rodrigues Marcela Giudicissi Bárbara Campos Lara Nogueira Luciana Saraiva Giuseppe Alexandre Romito Cláudio Mendes Pannuti The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial Trials Periodontitis Periodontal Disease Metronidazole Amoxicillin Scaling and Root Planing Treatment |
author_facet |
Magda Feres Belén Retamal-Valdes Maria Josefa Mestnik Luciene Cristina de Figueiredo Marcelo Faveri Poliana M. Duarte Aretuza Fritoli Elisangela Faustino Maria Luisa Silveira Souto Michelle de Franco Rodrigues Marcela Giudicissi Bárbara Campos Lara Nogueira Luciana Saraiva Giuseppe Alexandre Romito Cláudio Mendes Pannuti |
author_sort |
Magda Feres |
title |
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
title_short |
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
title_full |
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
title_fullStr |
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
title_full_unstemmed |
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
title_sort |
ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-03-01 |
description |
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. |
topic |
Periodontitis Periodontal Disease Metronidazole Amoxicillin Scaling and Root Planing Treatment |
url |
http://link.springer.com/article/10.1186/s13063-018-2540-8 |
work_keys_str_mv |
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doaj-ae1d184043e54864b72b4829120e9e532020-11-24T23:59:37ZengBMCTrials1745-62152018-03-011911710.1186/s13063-018-2540-8The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trialMagda Feres0Belén Retamal-Valdes1Maria Josefa Mestnik2Luciene Cristina de Figueiredo3Marcelo Faveri4Poliana M. Duarte5Aretuza Fritoli6Elisangela Faustino7Maria Luisa Silveira Souto8Michelle de Franco Rodrigues9Marcela Giudicissi10Bárbara Campos Lara Nogueira11Luciana Saraiva12Giuseppe Alexandre Romito13Cláudio Mendes Pannuti14Department of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDepartment of Periodontology, Dental Research Division, Guarulhos UniversityDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao PauloAbstract 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.http://link.springer.com/article/10.1186/s13063-018-2540-8PeriodontitisPeriodontal DiseaseMetronidazoleAmoxicillinScaling and Root PlaningTreatment |