Evidence map›Paper›PMID 33858486›Full record

ArticleTrials2021

Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial.

Belen Retamal-Valdes, Wim Teughels, Laryssa Macedo Oliveira, Rebeca Nascimento da Silva, Aretuza Fritoli, Patricia Gomes, Geisla Mary Silva Soares, Natalie Temporão, Camila Pinheiro Furquim, Poliana Mendes Duarte and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03733379 (Clinical, Microbiological and Immunological Evaluation of the Effects of Systemic Probiotics in the Periodontal Treatment), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 30% of its field
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.

NCT03733379 phase3unknown statusnot on this map

Clinical, Microbiological and Immunological Evaluation of the Effects of Systemic Probiotics in the Periodontal Treatment

TypeinterventionalSponsorBelén Retamal-ValdesRan2018 to 2021Enrolled176ConditionsPeriodontitisArmsScaling and root planing, Metronidazole and Amoxicillin placebos, Metronidazole, Amoxicillin, Probiotic
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. 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

14 authors at 4 institutions in 3 countries.

Belen Retamal-ValdesDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Wim TeughelsDepartment of Oral Health Sciences, Periodontology, Katholieke Universiteit Leuven (KULeuven), Leuven, Belgium.
Laryssa Macedo OliveiraDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Rebeca Nascimento da SilvaDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Aretuza FritoliDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Patricia GomesDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Geisla Mary Silva SoaresDepartment of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil.
Natalie TemporãoDepartment of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil.
Camila Pinheiro FurquimDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Poliana Mendes DuarteDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Helio DoyleDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Marcelo FaveriDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Luciene Cristina FigueiredoDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil. lucienedefigueiredo@gmail.com.ORCID http://orcid.org/0000-0002-2766-526X
Magda FeresDepartment of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, Guarulhos, SP, 07023-070, Brazil.
Guarulhos University · BRUniversidade Federal do Paraná · BRKU Leuven · BEUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, generalized. More recently, probiotics have also been suggested as a promising adjunctive treatment for periodontal diseases due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this randomized clinical trial (RCT) is to evaluate the clinical, microbiological, and immunological effects of probiotics as adjuncts to SRP alone or with MTZ+AMX in the treatment of periodontitis.

methodsSubjects with periodontitis are being randomly assigned to receive (i) SRP alone, or with (ii) two probiotic lozenges/day for 90 days (Prob), (iii) MTZ (400 mg) and AMX (500 mg) thrice a day (TID) for 14 days (MTZ+AMX), or (iv) Prob and MTZ+AMX. Subjects are being monitored for up to 12 months post-treatment. Nine subgingival plaque samples per patient are being collected at baseline and at 3, 6, and 12 months post-therapy and analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species. Peripheral blood and gingival crevicular fluid (GCF) of four randomly selected periodontal sites will be analyzed by means of a multiplex fluorescent bead-based immunoassay for 17 cyto/chemokines. STATISTICAL ANALYSES: The significance of differences in each group (over the course of the study) will be sought using repeated measures ANOVA or Friedman tests and among groups (at each time point) using either ANOVA/ANCOVA or Kruskal-Wallis tests, depending on normality of the data. The chi-square test will be used to compare differences in the frequency of subjects achieving the clinical endpoint for treatment (≤ 4 sites with PD ≥ 5 mm) at 1 year and of self-perceived adverse effects. A stepwise forward logistic regression analysis will be performed in order to investigate the impact of different predictor variables on the percentage of patients achieving the clinical endpoint for treatment. The Number Needed to Treat (NNT) with different treatment protocols will be also calculated. Statistical significance will be set at 5%.

trial registrationClinicalTrials.gov NCT03733379. Registered on November 7, 2018.

Indexed as

Chronic PeriodontitisProbioticsAmoxicillinAnti-Bacterial AgentsDental ScalingDouble-Blind MethodHumansMetronidazoleRandomized Controlled Trials as TopicRoot PlaningAmoxicillinAnti-Bacterial AgentsMetronidazoleAmoxicillinMetronidazolePeriodontitisProbioticScaling and root planingTreatment

Identifiers

PMID33858486
PMCPMC8048221
OpenAlexW3133599326

What OpenQuestion holds

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LicenceCC BY
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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.