Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy (AMX-Perio)

November 21, 2017 updated by: Luis Antonio Noriega Frontado, Universidad El Bosque, Bogotá

Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bogotá D.C
      • Bogotá, Bogotá D.C, Colombia, 1101
        • Luis Antonio Noriega Frontado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment
Drug: Amoxicillin
Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
Other Names:
  • Intensive Periodontal treatment
Placebo Comparator: PLACEBO
Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment
Other: Placebo
Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment
Other Names:
  • Intensive Periodontal treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
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
baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
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
baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
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
baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of Pressure blood
Time Frame: baseline, immediately finished the treatment
Millimeter of mercury (mmHg)
baseline, immediately finished the treatment
Change of Heart rate.
Time Frame: baseline, immediately finished the treatment
Beats per Minute (BPM)
baseline, immediately finished the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad El Bosque, Bogotá

Investigators

  • Principal Investigator: Luis Antonio Noriega Frontado, MSc (c), El Bosque University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Anticipated)

April 30, 2018

Study Completion (Anticipated)

July 31, 2018

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIBObosque

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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