Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy

NCT03354338 | Unknown Phase 2 DMC

• 1 other identifier: UIBObosque
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Periodontitis; Bacteremia

Keywords

Periodontal disease; Bacteremia; Amoxicilline; Inflamatory markers

Outcome Measures

Primary Outcomes (4)

• Incidence bacteria "Change"

  absence or presence bacterial in blood

  baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th

• Change of Nature of the bacteria

  bacterial strain

  baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th

• Change of magnitude of bacteremia

  Colony forming units (CFU)

  baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th

• Duration of bacteremia

  Bacteremia´s minutes

  baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th

Secondary Outcomes (6)

• Change of levels of Interleukin

  baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later

• Change of C Reactive Protein (CRP)

  baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later

• Change of levels of plasma haemostatic (D-dimer)

  baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later

• Change of von Willebrand factor antigen (r-WF:Ag)

  baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later

• Change of Pressure blood

  baseline, immediately finished the treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment

Drug: Amoxicillin

PLACEBO

PLACEBO COMPARATOR

Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment

Other: Placebo

Interventions

Amoxicillin DRUG

Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment

Also known as: Intensive Periodontal treatment

Experimental Group

Placebo OTHER

Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment

Also known as: Intensive Periodontal treatment

PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead

Study Sites (1)

Luis Antonio Noriega Frontado

Bogotá, Bogota D.C., 1101, Colombia

Location

Related Publications (10)

• 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.

  PMID: 26125117 BACKGROUND

• 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.

  PMID: 26021225 BACKGROUND

• 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.

  PMID: 15312097 BACKGROUND

• 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.

  PMID: 8910831 BACKGROUND

• 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.

  PMID: 21392048 BACKGROUND

• 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.

  PMID: 12010523 BACKGROUND

• 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.

  PMID: 16644317 BACKGROUND

• 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.

  PMID: 17214734 BACKGROUND

• 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.

  PMID: 11288795 BACKGROUND

• 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.

  PMID: 25467569 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Bacteremia; Periodontal Diseases

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luis Antonio Noriega Frontado, MSc (c)

  El Bosque University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, Investigator, Outcomes Assessor and Statistic. The treatment codes of the study were not accessible to the investigators and to the examiner until the data will be analyzed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc (c) Dentistry Science

Model Details: A triple-blind randomized controlled trial with 90 participants will be conducted. Participants will be assigned using block randomization in two groups and will received intensive periodontal therapy under local anaesthesia. Test group pre-medication with 2 gr of oral amoxicilline 1 hour before treatment. Control group with 2 gr of placebo 1 hour before treatment. Samples of blood will be taken at baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th to asses bacteremia and inflammatory markers

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 27, 2017
• Study Start: September 21, 2017
• Primary Completion: April 30, 2018
• Study Completion: July 31, 2018
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)