Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy

Overview

There are not published studies evaluating the incidence, nature, magnitude and/or duration of bacteremia after periodontal treatment. The pre-surgical antibiotics have been studied particullary over Gram positive bacterial but not over gram negative bacterial and their secondary effects over the systemic pro-inflamation. Objective: to evaluate the efficacy of intensive periodontal therapy and pre-medication with oral amoxicilline on inflammatory bio-markers and the incidence, duration and magnitude of bacteremia in patients with chronic periodontitis.

Full Title of Study: “Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2018

Detailed Description

A randomized, triple-blind clinical trial with 90 participants will be conducted (age range18-65 years) with chronic periodontitis will be received and intensive periodontal therapy under local anaesthesia. Participants will be randomly assigned using block randomization in two groups. Test group premedication with 2 gr of oral amoxicilline 1 hour before periodontal treatment and control group with 2 gr of placebo 1 hour before treatment. High-sensitivity assays will be used to quantify serum concentrations of inflammatory marker (Interleukin (IL-1β), Interleukin 6, Tumour necrosis factor α, MCP 1, C Reactive Protein (CRP), plasma haemostatic (D-dimer), and von Willebrand factor antigen (r-WF:Ag). Samples of blood will be taken at baseline (before treatment), inmediatly finished the treatment, 30 minutes and 1, seven and 30 days after treatment to asses bacteremia and inflammatory markers. Bacterial isolation and identification: Bacterial colonies will be isolated on both selective and nonselective culture medium for aerobes and anaerobes bacteria. Sensitive Digital quantitative polymerase chain reaction will be used to quantify bacteria. Concentrations of CPRus, inflammatory, haemostatic and endotellial cell activation markers will be quantified by high-sensitive enzyme liked inmunosorbent assays according to the manufacturer´s protocol. For each cytokine, comparisons between groups will be made by time. The levels of cytokines expressed in picograms will be transformed into international units for the statistical analysis. In case it follows a normal distribution, an analysis of variance (ANOVA) for repeated measurements between groups with post hoc corrections made by Wilcoxon test will be used. In case it doesn´t follow a normal distribution, Non parametric test such as Friedman´s test will be used. Values of p<0.05 will be accepted as statiscally significant.

Interventions

  • Drug: Amoxicillin
    • Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
  • Other: Placebo
    • Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment

Arms, Groups and Cohorts

  • Experimental: Experimental Group
    • Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment
  • Placebo Comparator: PLACEBO
    • Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment

Clinical Trial Outcome Measures

Primary Measures

  • Incidence bacteria “Change”
    • Time Frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
    • absence or presence bacterial in blood
  • Change of Nature of the bacteria
    • Time Frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
    • bacterial strain
  • Change of magnitude of bacteremia
    • Time Frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
    • Colony forming units (CFU)
  • Duration of bacteremia
    • Time Frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
    • Bacteremia´s minutes

Secondary Measures

  • Change of levels of Interleukin
    • Time Frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
    • Levels pg/ml
  • Change of C Reactive Protein (CRP)
    • Time Frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
    • Levels mg/L
  • Change of levels of plasma haemostatic (D-dimer)
    • Time Frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
    • Levels ng/ml
  • Change of von Willebrand factor antigen (r-WF:Ag)
    • Time Frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
    • Levels ng/ml
  • Change of Pressure blood
    • Time Frame: baseline, immediately finished the treatment
    • Millimeter of mercury (mmHg)
  • Change of Heart rate.
    • Time Frame: baseline, immediately finished the treatment
    • Beats per Minute (BPM)

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects with chronic periodontitis (Ameriacam Academy of Periodontology 2015), having at least 2 teeth for quadrant with periodontal probing pockets depth ≥ 5 mm. Exclusion Criteria:

  • Pregnant and lactating women, Diabetes, hypertension, Obesity, Allergy to penicillin, consumption of systemic antimicrobial or anti-inflamatory drugs in the last 2 months, Autoimmune diseases, patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and history of rheumatic fever.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidad El Bosque, Bogotá
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luis Antonio Noriega Frontado, MSc (c) Dentistry Science – Universidad El Bosque, Bogotá
  • Overall Official(s)
    • Luis Antonio Noriega Frontado, MSc (c), Principal Investigator, El Bosque University

References

American Academy of Periodontology Task Force Report on the Update to the 1999 Classification of Periodontal Diseases and Conditions. J Periodontol. 2015 Jul;86(7):835-8. doi: 10.1902/jop.2015.157001. Epub 2015 May 27. No abstract available.

Arduino PG, Tirone F, Schiorlin E, Esposito M. Single preoperative dose of prophylactic amoxicillin versus a 2-day postoperative course in dental implant surgery: A two-centre randomised controlled trial. Eur J Oral Implantol. 2015 Summer;8(2):143-9.

Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.

Beck J, Garcia R, Heiss G, Vokonas PS, Offenbacher S. Periodontal disease and cardiovascular disease. J Periodontol. 1996 Oct;67(10 Suppl):1123-37. doi: 10.1902/jop.1996.67.10s.1123.

Castillo DM, Sanchez-Beltran MC, Castellanos JE, Sanz I, Mayorga-Fayad I, Sanz M, Lafaurie GI. Detection of specific periodontal microorganisms from bacteraemia samples after periodontal therapy using molecular-based diagnostics. J Clin Periodontol. 2011 May;38(5):418-27. doi: 10.1111/j.1600-051X.2011.01717.x. Epub 2011 Mar 11.

Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.

D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84. doi: 10.1016/j.ahj.2005.06.018.

D'Aiuto F, Parkar M, Tonetti MS. Acute effects of periodontal therapy on bio-markers of vascular health. J Clin Periodontol. 2007 Feb;34(2):124-9. doi: 10.1111/j.1600-051X.2006.01037.x. Epub 2007 Jan 3.

Daly CG, Mitchell DH, Highfield JE, Grossberg DE, Stewart D. Bacteremia due to periodontal probing: a clinical and microbiological investigation. J Periodontol. 2001 Feb;72(2):210-4. doi: 10.1902/jop.2001.72.2.210.

Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.

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