Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Dental Staining
研究概览
简要总结
The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. The purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.
详细描述
Test panel
The test panel will be recruited from the dental students of the Lutheran University of Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their medical and dental history. Written and oral explanations detailing the study purpose and design will be given for each subject. Subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. If the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers.
The following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar.
Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - Absence of calculus; 1 - Presence of calculus.
Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18-35 years
- •No relevant medical conditions that could interfere on the periodontal health
- •Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites
- •Willingness to comply
排除标准
- •Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination
- •Oral mucosal lesions
- •Need for antibiotic premedication
- •History of hypersensitivity to chlorhexidine
- •Any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses)
- •Exclusion criteria during the study:
- •Individuals that wanted to give up the study
- •Any acute process like allergic reaction to the product or gingival abcess
- •Necessity to use of any antibiotic or anti-inflammatory
- •Use of any other rinsing product farther the chlorhexidine's rinses
- •Individuals who did any mechanical biofilm control
结局指标
主要结局
Dental Staining
时间窗: 21 days
次要结局
- Dental calculus formation(21 days)