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Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy

NCT ID: NCT03354338

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Periodontitis Bacteremia

Keywords

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Periodontal disease Bacteremia Amoxicilline Inflamatory markers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

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

PLACEBO

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Amoxicillin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Intensive Periodontal treatment Intensive Periodontal treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad El Bosque, Bogotá

OTHER

Sponsor Role lead

Responsible Party

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Luis Antonio Noriega Frontado

MSc (c) Dentistry Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis Antonio Noriega Frontado, MSc (c)

Role: PRINCIPAL_INVESTIGATOR

El Bosque University

Locations

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Luis Antonio Noriega Frontado

Bogotá, Bogota D.C., Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type BACKGROUND
PMID: 26125117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26021225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15312097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8910831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21392048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12010523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16644317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17214734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11288795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25467569 (View on PubMed)

Other Identifiers

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UIBObosque

Identifier Type: -

Identifier Source: org_study_id