2.1. Study Design
bleeding, periodontitis, candidiasis, PD, psychiatric, allergies
BLEEDING, AUTOIMMUNE DISORDERS, PERIODONTITIS, HIV INFECTION, DIABETES MELLITUS, CANDIDIASIS, DISORDERS, ALLERGIES
This study was conducted as a double-blinded, randomized, placebo-controlled clinical trial of 6 months with a parallel design of three independent groups by a 1:1:1 allocation ratio.It was established that 19 patients per group are needed to detect a significant mean difference of 1 mm in PPD reduction between groups, assuming a common standard deviation of 1 mm, 80% power, and a significance level of 0.05. The Pitman asymptotic relative efficiency correction was used in the sample size calculations to account for the use of nonparametric tests. Considering an anticipated drop-out rate of ~10%, it was decided to enroll at least 21 patients in each group.This study included a cohort of 100 patients equally divided into one of the three groups: A, B, and C. Subjects were selected from patients of the Department of Periodontology of the “Victor Babeș” University of Medicine and Pharmacy Timisoara, Romania. The study design was approved by the Committee for Research Ethics of the Victor Babes University of Medicine and Pharmacy Timisoara (approval No. 20/03.09.2018) and conforms to the requirements of the Declaration of Helsinki as adopted by the 18th World Medical Assembly in 1964 and subsequently revised. All subjects were informed about the nature and purpose of this study, and each subject signed an informed consent document giving permission for the dental procedures and sampling of biological material. This study was carried out between October 2018 and February 2021. This study is registered in the ISRCTN89207035 Registry of Clinical Trials and follows the guidelines described in the CONSORT 2010 statement on clinical trials.Diagnosis (staging and grading) of periodontitis was based on the criteria outlined in The New Classification Scheme from 2018 [All subjects were diagnosed with periodontitis stage III and IV. All participants fulfilled the following inclusion criteria: subjects aged over 25 years, at least 8 sites with PD ≥ 5 mm and showing bleeding on probing, clinical attachment loss ≥ 5 mm, patients who have not undergone periodontal therapy within the last 12 months.Patients with the following conditions were excluded: clinically relevant psychiatric disorders, alcohol consumption, autoimmune disorders, HIV infection, untreated diabetes mellitus, pregnancy or breastfeeding, patients who have received periodontal therapy in the last 12 months, patients who reported local and/or systemic antibiotic therapy within the 3 months before the baseline examination of this study, candidiasis, allergies to piperacillin, tazobactam, doxycycline, or to any tetracycline or penicillin or to any excipient of the products used, systemic medication that can influence the clinical features of periodontitis, patients who have rinsed or irrigated with antiseptics less than a month before the initial examination, conditions that require antibiotic protection.