Clinical Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis: Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Efficacy of a mouthwash containing 5% propolis for the control of gingivitis
研究概览
简要总结
Mouthwash based on medicinal plants and propolis can be easily found in the Brazilian market even if it has not been tested in reliable clinical trials on its efficacy or possible unpleasant side effects like the ones which alter the hard and soft oral tissues. The aim of this study was to obtain preliminary evidence of efficacy of an alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Were chosen twenty-five subjects that are UFMG employees and individuals who would begin treatment on an extension project called Supportive Periodontal Therapy at the Faculty of Dentistry of Federal University of Minas Gerais, Belo Horizonte, from August to December 2009. The subjects went through a dental prophylaxis before starting rinse. They were then instructed to rinse twice a day for a minute, immediately after brushing (morning and night), using the 10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a clinical evaluation which considered changes in the soft and hard oral tissues and involved collecting plaque and gingivitis indexes. On their last appointment the subjects answered a questionnaire about their level of appreciation and acceptability of the mouthwash. Compliance with the treatment was also evaluated through an attendance form. For the statistic analysis we used BioEstat 4.0 and Excel 2007.
详细描述
The first reference to mouthrinse as a formal practice is credited to Chinese medicine, about 2700 B.C.E., to treatment the diseases of the gums (Fischman, 1997).
The gram-positive and gram-negative bacteria that compose oral biofilms produces many metabolites that induce gingival inflammation (that is, gingivitis). Gingivitis can lead to periodontitis, a condition in which gingival and bone tissues are destroyed. The majority of the population may not perform mechanical plaque removal sufficiently. Thus, antimicrobial mouthrinses that improve daily home care may provide an effective way of removing or controlling bacterial plaque to limit gingivitis and periodontitis (Haffajee et al., 2008).
The main indications are either the improvement of dental health (plaque and gingivitis elimination in particular) or the prevention of infections caused by bacteria of the oral cavity in specific situations, such as tooth extraction, intraoral surgical procedures or immune suppression due to cancer therapy or transplantation. The use of antimicrobial mouthrinses has been proposed to reduce the levels of oral bacteria, specially Streptococcus mutans (Kocak et al., 2009).
In fact, it has been shown that chemotherapeutic mouthrinses are an effective adjunct to regular brushing and flossing for patients with gingivitis, providing a clinically significant benefit in the reduction of plaque and gingivitis (Haffajee et al., 2008).
Propolis is a resinous substance collected by honeybees from buds and exudates of certain trees and plants, and stored inside their hives. It has been used in folk medicine from ancient times to treat various ailments (Kunimasa et al., 2009).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years
- •generally good health
- •not pregnant nor breastfeeding
- •a minimum of 20 sound, natural teeth
- •a mean plaque index (PI) (Turesky modification of the Quigley-Hein Plaque Index, 1970) of at least 1.5 or more
- •a mean gingival index (GI) (Talbott modification Gingival Index of the Löe-Silness, 1977) of at least 1.0 or more
- •signing the terms of agreement
排除标准
- •Subjects with orthodontic appliances or removable prosthetics
- •Subjects with tumors of the soft or hard oral tissues
- •Subjects with advanced periodontal disease
- •Subjects that received antibiotic therapy 2 weeks before the start of the study
- •Subjects with hipersensibility to propolis confirmed
结局指标
主要结局
Efficacy of a mouthwash containing 5% propolis for the control of gingivitis
时间窗: 90 days
Difference in the Gingival Index scores between the start and the end of the study.
次要结局
- Efficacy of a mouthwash containing 5% propolis for the control of plaque(90 days)