Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence bacteria "Change"
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with chronic periodontitis (Ameriacam Academy of Periodontology 2015), having at least 2 teeth for quadrant with periodontal probing pockets depth ≥ 5 mm.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment
干预措施: Amoxicillin (Drug)
PLACEBO
Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment
干预措施: Placebo (Other)
结局指标
主要结局
Incidence bacteria "Change"
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Bacteremia´s minutes
次要结局
- Change of C Reactive Protein (CRP)(baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later)
- Change of levels of plasma haemostatic (D-dimer)(baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later)
- Change of levels of Interleukin(baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later)
- Change of Pressure blood(baseline, immediately finished the treatment)
- Change of Heart rate.(baseline, immediately finished the treatment)
- Change of von Willebrand factor antigen (r-WF:Ag)(baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later)
研究者
Luis Antonio Noriega Frontado
MSc (c) Dentistry Science
Universidad El Bosque, Bogotá