EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Substantivity
研究概览
简要总结
Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine. Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There are no published studies evaluating the substantivity of hypochlorous acid compared to CHX. Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a placebo.
详细描述
Materials and Methods
A randomized, double-blind clinical trial with 75 participants was conducted. Participants were randomly assigned using block randomization in five groups: HOCl 0.025% and 0.05%, CHX 0.12 and 0.2% and sterile water as placebo. Participants were instructed to use each rinse with 10 ml of each solution for 30 seconds after dental prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7 hours to assess substantivity establishing the bacterial viability by the fluorescence method with the SYTO 9/propidium iodide dual staining. All participants were assessed with the Turesky visible plaque index at baseline and at 7 hours and adverse events were assessed. For the comparisons of the viability of the different rinses between times, the statistical test of generalized linear mixed model [GT1] adjusted to treatment, time and treatment-time interaction was used.
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
The treatment codes of the study were not accessible to the investigators and to the examiner until the data were analyzed
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Dentate young men with minimum 22 teeth were considered eligible for the study. Participants should have good dental and gingival status (DMFT index ≤ 3, median of Lobene gingival index ≤ 1) and detectable levels of dental plaque at 7 hours of brushing during the selection process.
排除标准
- •Exclusion criteria included smoking, orthodontic, orthopedic or rehabilitation treatment, cavitated carious lesions and consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months.
研究组 & 干预措施
HOCl 0.025%
15 ml of Hypochlorous acid mouthwash at 0.025%
干预措施: Hypochlorous Acid (Drug)
HOCl 0.05%
15 ml of Hypochlorous acid mouthwash at 0.05%
干预措施: Hypochlorous Acid (Drug)
CHX 0.2%
15 ml of chlorhexidine mouthwash at 0.2%
干预措施: Chlorhexidine (Drug)
CHX 0.025%
15 ml of chlorhexidine at mouthwash0.025%
干预措施: Chlorhexidine (Drug)
Placebo
15 ml of Sterile water
干预措施: Placebo (Other)
结局指标
主要结局
Substantivity
时间窗: Baseline, 30 Seconds, 1, 3, 5 and 7 hours
Viability reduction (VR) was calculated for each saliva sample by the difference in the percentage of viable bacteria between two times.
次要结局
- Plaque Index(Baseline and 7 hours)
研究者
Gloria Inés Lafaurie
Magister Clinical Epidemiology
Universidad El Bosque, Bogotá