A Castor Bean Solution Reduces Complete Denture Biofilm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Denture area covered with biofilm
研究概览
简要总结
To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of complete denture biofilm, comparing it with two products available on the market (sodium hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed to brush their dentures after meals and once a day, for a period of 07 days, immerse them in the following solutions: A - Control: Physiological solution(20 minutes). B - Polident alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based solution(20 minutes). The participants immersed their dentures in each of the solutions, according to a randomized sequence. For biofilm quantification, before (Baseline) and after the use of each product, the internal surfaces of maxillary complete dentures were revealed (1% neutral red), photographed and the stained biofilm was quantified with the aid of software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .
详细描述
The study sought to minimize the occurrence of bias, and whenever possible sought to "blind" the parties involved (researchers, volunteers and statisticians), since none of them had knowledge of the allocation of treatments. The present study also followed the criteria described in the CONSORT Declaration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders, age-range 45 years and over, completely edentulous, in a good state of general health, wearers of maxillary complete dentures fabricated of heat polymerized acrylic resin and acrylic artificial teeth.
排除标准
- •Dentures that had been used for less than 03 years, and broken, fractured or relined dentures.
结局指标
主要结局
Denture area covered with biofilm
时间窗: 8 weeks
The volunteers were instructed to brush their dentures ,3 times a day and use the following chemical immersion methods, only once a day after dinner: A)Physiological solution .B) 1% Sodium Hypochlorite .C) Polident Alkaline Peroxide .D) 2,0% Castor bean solution . All the volunteers used one of the four chemical methods in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure.On the first day and after 07 days of using the interventions, the internal surfaces of dentures were revealed with 1% neutral red solution and photographed with a digital photographic camera. Biofilm was measured on the photographic images of the complete dentures, using the computerized quantitative method "ImageTool". After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .
次要结局
未报告次要终点
研究者
Ingrid Machado de Andrade
Phd
University of Sao Paulo