A Phase 2 interventional study of Amoxicillin and Placebo in Chronic Periodontitis and Bacteremia, sponsored by Universidad El Bosque, Bogotá. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Universidad El Bosque, Bogotá · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment
Drug: Amoxicillin
Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment
Other: Placebo
Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
Also known as: Intensive Periodontal treatment
Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment
Also known as: Intensive Periodontal treatment
Incidence bacteria "Change"
absence or presence bacterial in blood
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Change of levels of Interleukin
Levels pg/ml
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of C Reactive Protein (CRP)
Levels mg/L
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of levels of plasma haemostatic (D-dimer)
Levels ng/ml
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of von Willebrand factor antigen (r-WF:Ag)
Levels ng/ml
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of Pressure blood
Millimeter of mercury (mmHg)
Time frame: baseline, immediately finished the treatment
Change of Heart rate.
Beats per Minute (BPM)
Time frame: baseline, immediately finished the treatment
Plan to share: No
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Universidad El Bosque, Bogotá