STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN. RANDOMIZED CONTROLLED CLINICAL TRIAL.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
研究概览
简要总结
Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections with relatively easy treatment and preventive features. The present study is aimed to determine if treating human individuals with chronic periodontitis, along with the use of antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if severity of periodontitis could be associated with a raise of systemic inflammatory biomarkers on baseline.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must be of legal age (≥ 18 years old)
- •voluntary participation and signed information consent
- •confirmed systemically healthy individual
- •at least 15 teeth present in mouth
- •Exclusion Criteria
- •pregnant women
- •antibiotic consumption 6 months before inclusion
- •HIV positive or AIDS
- •Allergic reactions to macrolides and specifically to azithromycin
- •Periodontal treatment 6 months before inclusion
排除标准
- 未提供
研究组 & 干预措施
Scaling and root planing plus Azithromycin
Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
干预措施: Scaling and root planing plus Azithromycin (Drug)
Scaling and root planing plus placebo
Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
干预措施: Scaling and root planing plus placebo (Drug)
结局指标
主要结局
EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.
时间窗: 3 months
High sensitive C reactive protein - hs-PCR levels evaluate the effect of periodontal therapy alone or with azithromycin on levels of high sensitivity C-reactive protein (hs CRP) in patients with chronic periodontitis
次要结局
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE(3 months)
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS(3 months)
- STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY(3 MONTHS)
研究者
Jorge Enrique Soto
periodontist Cert. DDS
Universidad del Valle, Colombia