Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
研究概览
简要总结
The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
详细描述
This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age from 18 years;
- •non-smokers;
- •have good general health;
- •present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.
排除标准
- •• positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
- •positive history of allergies at using Triclosan;
- •pregnant or lactating patients;
- •patients in use of fixed orthodontic appliance.
研究组 & 干预措施
0.12% Clorhexidine with alcohol
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine with alcohol (Drug)
0.12% Clorhexidine with alcohol
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
干预措施: placebo (Drug)
0.12% Clorhexidine with alcohol
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine without alcohol (Drug)
0.12% Clorhexidine without alcohol
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine with alcohol (Drug)
0.12% Clorhexidine without alcohol
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
干预措施: placebo (Drug)
0.12% Clorhexidine without alcohol
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine without alcohol (Drug)
control
placebo 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine with alcohol (Drug)
control
placebo 15ml every 12 hour for 4 days
干预措施: placebo (Drug)
control
placebo 15ml every 12 hour for 4 days
干预措施: 0.12% Clorhexidine without alcohol (Drug)
结局指标
主要结局
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
时间窗: 24hours
The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).
次要结局
未报告次要终点
研究者
Patricia Weidlich
Doctor
Federal University of Rio Grande do Sul