Clinical Evidence Efficacy of a Mouthwash Containing Propolis for the Control of Plaque and Gingivitis: Phase III, Randomized, Double-blind Comparison With Mouthwash Chlorhexidine Base.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
研究概览
简要总结
Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I.
详细描述
Chemical characterization of propolis by HPLC (High-performance liquid chromatography), antimicrobial testing against pathogens and cariogenic. Studies in vitro on anti-inflammatory activity, cytotoxicity tests of green propolis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •age ranging from 18 to 60 years
- •minimum of 20 natural teeth
- •mean plaque index (PI)of at least 1.5
- •an average gingival index (GI), at least less than 1.0.
排除标准
- •Individuals with orthodontic appliances or removable dentures,
- •Individuals whit tumors of soft tissue or hard mouth, and advanced periodontal disease,
- •Indivuduals whit antibiotic therapy 2 weeks prior to study initiation, or with known hypersensitivity propolis are also excluded.
研究组 & 干预措施
Propolis
alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.
干预措施: chlorhexidine (Drug)
chlorhexidine
chlorhexidine used on the control of plaque and gingivitis.
干预措施: Propolis (Drug)
结局指标
主要结局
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
时间窗: 8-12 weeks
次要结局
- PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS(90 days)
研究者
Andre Oliveira Naufel de Toledo
Principal Investigator
Federal University of Minas Gerais