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

Trials

Wim Teughels¹  Laryssa Macedo Oliveira²  Rebeca Nascimento da Silva²  Aretuza Fritoli²  Magda Feres²  Belen Retamal-Valdes²  Patricia Gomes²  Luciene Cristina Figueiredo²  Helio Doyle²  Marcelo Faveri²  Poliana Mendes Duarte³  Camila Pinheiro Furquim⁴  Natalie Temporão⁵  Geisla Mary Silva Soares⁵ 

[1] Department of Oral Health Sciences, Periodontology, Katholieke Universiteit Leuven (KULeuven), Leuven, Belgium;Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, 07023-070, Guarulhos, SP, Brazil;Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, 07023-070, Guarulhos, SP, Brazil;Department of Periodontology, College of Dentistry, University of Florida, Gainesville, FL, USA;Department of Periodontology, Dental Research Division, Centro de Pós-Graduação e Pesquisa-CEPPE, Guarulhos University, Praça Tereza Cristina, 229 Centro, 07023-070, Guarulhos, SP, Brazil;Department of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil;Department of Stomatology, Federal University of Parana, Curitiba, Parana, Brazil;

关键词: Periodontitis;    Probiotic;    Metronidazole;    Amoxicillin;    Scaling and root planing;    Treatment;   

DOI  :  10.1186/s13063-021-05246-0

来源: Springer

【 摘 要 】

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 analysesThe 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.

【 授权许可】

CC BY