Bacteremia, Chronic Periodontitis
Conditions
Keywords
Periodontal disease, Bacteremia, Amoxicilline, Inflamatory markers
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.
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.
Interventions
DRUGAmoxicillin
Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
OTHERPlacebo
Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment
Sponsors
Universidad El Bosque, Bogotá
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence bacteria Change | 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 |
| Change of Nature of the bacteria | baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th | bacterial strain |
| Change of magnitude of bacteremia | 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) |
| Duration of bacteremia | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of Pressure blood | baseline, immediately finished the treatment | Millimeter of mercury (mmHg) |
| Change of levels of Interleukin | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | Levels pg/ml |
| Change of Heart rate. | baseline, immediately finished the treatment | Beats per Minute (BPM) |
| Change of C Reactive Protein (CRP) | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | Levels mg/L |
| Change of levels of plasma haemostatic (D-dimer) | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | Levels ng/ml |
| Change of von Willebrand factor antigen (r-WF:Ag) | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | Levels ng/ml |
Countries
Colombia
Outcome results
None listed