Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intragel bacterial viability: baseline vs 5 minutes
研究概览
简要总结
The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy volunteers
- •Age between 20-45 years
- •Presence of minimum 24 permanent teeth
- •No evidence of gingivitis or periodontitis (CPITN= 0)
- •No presence of untreated caries at the start of the study
排除标准
- •Smoker or ex-smoker
- •Presence of dental protheses or orthodontic appliances
- •Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
- •Presence of any systemic disease that could alter saliva production or composition
研究组 & 干预措施
0.20% CHX gel
Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
干预措施: 0.20% CHX gel on saliva (Drug)
0.20% CHX gel
Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
干预措施: 0.20% CHX gel on oral biofilm (Drug)
0.20% CHX and Cymenol gel
Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
干预措施: 0.20% CHX and Cymenol gel on saliva (Drug)
0.20% CHX and Cymenol gel
Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.
干预措施: 0.20% CHX and Cymenol gel on oral biofilm (Drug)
结局指标
主要结局
Intragel bacterial viability: baseline vs 5 minutes
时间窗: Baseline, 5 minutes
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes
Intragel bacterial viability: baseline vs 5 hours
时间窗: Baseline, 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours
Intragel bacterial viability: 5 minutes vs 7 hours
时间窗: 5 minutes, 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours
Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: Baseline
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intragel bacterial viability: baseline vs 3 hours
时间窗: Baseline, 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours
Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intragel bacterial viability: baseline vs 1 hour
时间窗: Baseline, 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour
Intragel bacterial viability: baseline vs 7 hours
时间窗: Baseline, 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours
Intragel bacterial viability: 5 minutes vs 5 hours
时间窗: 5 minutes, 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours
Intragel bacterial viability: 5 minutes vs 1 hour
时间窗: 5 minutes, 1 hour
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour
Intragel bacterial viability: 5 minutes vs 3 hours
时间窗: 5 minutes, 3 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours
Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: 5 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: 7 hours
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel
时间窗: 5 minutes
Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.
次要结局
未报告次要终点
研究者
Inmaculada Tomás
Professor
University of Santiago de Compostela