Evidence map›Paper›PMID 29587808›Full record

ArticleTrials2018

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

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 and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02954393 (Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02954393 naunknown statusnot on this map

Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.

TypeinterventionalSponsorBelén Retamal-ValdesRan2015 to 2020Enrolled180ConditionsChronic PeriodontitisArmsScaling and root planing, Metronidazole active phase, Metronidazole healing phase, Amoxicillin active phase, Amoxicillin healing phase
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Quorum-quenching enzyme Est816 assisted antibiotics against periodontitis induced byFrontiers in cellular and infection microbiology · 2024
    Article
  5. Non-surgical Periodontal Treatment: SRP and Innovative Therapeutic Approaches.Advances in experimental medicine and biology · 2022
    Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Magda FeresDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil. mferes@ung.br.ORCID http://orcid.org/0000-0002-2293-3392
Belén Retamal-ValdesDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Maria Josefa MestnikDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Luciene Cristina de FigueiredoDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Marcelo FaveriDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Poliana M DuarteDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Aretuza FritoliDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Elisangela FaustinoDepartment of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
Maria Luisa Silveira SoutoDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Michelle de Franco RodriguesDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Marcela GiudicissiDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Bárbara Campos Lara NogueiraDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Luciana SaraivaDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Giuseppe Alexandre RomitoDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.
Cláudio Mendes PannutiDivision of Periodontics, Department of Stomatology, School of Dentistry, University of Sao Paulo, São Paulo, Brazil.

Funding

São Paulo Research Foundation (FAPESP, Brazil) 2016/10958-5
6 · The paper itself

Abstract

backgroundThe 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.

methodsSubjects 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 registrationClinicalTrials.gov , NCT02954393 . Registered on 3 November 2016.

Indexed as

AdultAmoxicillinAnti-Bacterial AgentsBrazilDental ScalingDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansMaleMetronidazoleMulticenter Studies as TopicPeriodontitisRandomized Controlled Trials as TopicRoot PlaningAmoxicillinAnti-Bacterial AgentsMetronidazoleAmoxicillinAntibioticsMetronidazolePeriodontal DiseasePeriodontitisScaling and Root PlaningTreatment

Identifiers

PMID29587808
PMCPMC5869787

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.