Abstract

Background

The 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.

Methods

Subjects 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 registration

ClinicalTrials.gov NCT03733379. Registered on November 7, 2018.

Details

Title
Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial
Author
Retamal-Valdes, Belen 1 ; Teughels, Wim 2 ; Oliveira, Laryssa Macedo 1 ; da Silva, Rebeca Nascimento 1 ; Fritoli, Aretuza 1 ; Gomes, Patricia 1 ; Soares, Geisla Mary Silva 3 ; Temporão, Natalie 3 ; Furquim, Camila Pinheiro 4 ; Duarte, Poliana Mendes 5 ; Doyle, Helio 1 ; Faveri, Marcelo 1 ; Figueiredo, Luciene Cristina 1   VIAFID ORCID Logo  ; Feres, Magda 1 

1  Guarulhos University, Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos, Brazil (GRID:grid.411869.3) (ISNI:0000 0000 9186 527X) 
2  Katholieke Universiteit Leuven (KULeuven), Department of Oral Health Sciences, Periodontology, Leuven, Belgium (GRID:grid.5596.f) (ISNI:0000 0001 0668 7884) 
3  Federal University of Parana, Department of Stomatology, Curitiba, Brazil (GRID:grid.20736.30) (ISNI:0000 0001 1941 472X) 
4  Guarulhos University, Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos, Brazil (GRID:grid.411869.3) (ISNI:0000 0000 9186 527X); Federal University of Parana, Department of Stomatology, Curitiba, Brazil (GRID:grid.20736.30) (ISNI:0000 0001 1941 472X) 
5  Guarulhos University, Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos, Brazil (GRID:grid.411869.3) (ISNI:0000 0000 9186 527X); University of Florida, Department of Periodontology, College of Dentistry, Gainesville, USA (GRID:grid.15276.37) (ISNI:0000 0004 1936 8091) 
Pages
283
Publication year
2021
Publication date
Dec 2021
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-021-05246-0
ProQuest document ID
2730332069
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.