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

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ClinicalTrials.gov Identifier: NCT03354338
Recruitment Status : Unknown
Verified November 2017 by Luis Antonio Noriega Frontado, Universidad El Bosque, Bogotá.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Luis Antonio Noriega Frontado, Universidad El Bosque, Bogotá

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Bacteremia Drug: Amoxicillin Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Intensive Periodontal treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Change of Pressure blood [ Time Frame: baseline, immediately finished the treatment ]
    Millimeter of mercury (mmHg)

  6. Change of Heart rate. [ Time Frame: baseline, immediately finished the treatment ]
    Beats per Minute (BPM)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354338


Locations
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Colombia
Luis Antonio Noriega Frontado
Bogotá, Bogotá D.C, Colombia, 1101
Sponsors and Collaborators
Universidad El Bosque, Bogotá
Investigators
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Principal Investigator: Luis Antonio Noriega Frontado, MSc (c) El Bosque University
More Information
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Publications:

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Responsible Party: Luis Antonio Noriega Frontado, MSc (c) Dentistry Science, Universidad El Bosque, Bogotá
ClinicalTrials.gov Identifier: NCT03354338    
Other Study ID Numbers: UIBObosque
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Antonio Noriega Frontado, Universidad El Bosque, Bogotá:
Periodontal disease
Bacteremia
Amoxicilline
Inflamatory markers
Additional relevant MeSH terms:
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Bacteremia
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents