Chronic Periodontitis Clinical Trial
— AMX-PerioOfficial 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.
Verified date | November 2017 |
Source | Universidad El Bosque, Bogotá |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Luis Antonio Noriega Frontado | Bogotá | Bogotá D.C |
Lead Sponsor | Collaborator |
---|---|
Universidad El Bosque, Bogotá |
Colombia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence bacteria "Change" | 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 | |
Primary | Change of Nature of the bacteria | bacterial strain | baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th | |
Primary | Change of magnitude of bacteremia | 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 | |
Primary | Duration of bacteremia | 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 | Change of levels of Interleukin | Levels pg/ml | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | |
Secondary | Change of C Reactive Protein (CRP) | Levels mg/L | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | |
Secondary | Change of levels of plasma haemostatic (D-dimer) | Levels ng/ml | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | |
Secondary | Change of von Willebrand factor antigen (r-WF:Ag) | Levels ng/ml | baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later | |
Secondary | Change of Pressure blood | Millimeter of mercury (mmHg) | baseline, immediately finished the treatment | |
Secondary | Change of Heart rate. | Beats per Minute (BPM) | baseline, immediately finished the treatment |
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