Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of participants with greater reduction of plaque regrowth and side effects.
研究概览
简要总结
In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-30 years
- •Good overall health without medical history or medications that could interfere with the study conduct.
- •Minimum of 6 teeth per quadrant.
- •Absence of probing depths ≥4mm.
排除标准
- •Allergy to CHX or to CPC.
- •Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
- •Any adverse medical background or long-term medications that could affect gingival conditions.
- •Having taken antibiotics in the previous three months.
- •Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
- •Pregnancy or breastfeeding.
- •Smokers of more than 5 cigarettes per day.
- •Orthodontic appliances.
- •Fixed or removable prostheses.
- •Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).
- •Severe dental crowding.
研究组 & 干预措施
0.12%NF
0.12% Chlorhexidine digluconate new formulation
干预措施: 0.12%NF (Drug)
0.03%NF
0.03% Chlorhexidine digluconate new formulation
干预措施: 0.03%NF (Drug)
PAT (Perio-Aid Treatment)
Commercialized 0.12% Clorhexidine digluconate (Perio-Aid Treatment, Dentaid, Spain)
干预措施: PAT (Drug)
结局指标
主要结局
Percentage of participants with greater reduction of plaque regrowth and side effects.
时间窗: Baseline to 4 days.
次要结局
未报告次要终点
研究者
Carolina Mor
Master in periodontics by Universitat Internacional de Catalunya.
Universitat Internacional de Catalunya