NCT01197105Unknown1 期
Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
Federal University of Paraíba2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gingival inflammation (Blood gingival index)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group: 10-12 years old
- •Presence of at least 20 dental elements
- •Do not use orthodontic fixed appliances
- •Simplified Oral Hygiene Index (S-OHI) is greater than 2
- •Levels of Microbiological Streptococcus mutans in saliva high (> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
- •Susceptibility to form biofilm and gingival inflammation
- •Absence of systemic disease
- •Not be under the use of antiseptic mouthwash in the last 3 months
排除标准
- 未提供
研究组 & 干预措施
Aroeira
Experimental
干预措施: Use of natural product (Schinus terebinthifolius) (Biological)
结局指标
主要结局
Gingival inflammation (Blood gingival index)
时间窗: baseline
In this time frame will be assessed the initial gingival inflammation in children.
Plaque amount
时间窗: Baseline
In this time will be assessed the initial oral hygiene condition of the children before the use of the product through the Simplified Oral Hygiene Index.
次要结局
- Gingival inflammation (Blood gingival Index)(After 7 days (t1))
- Gingival inflammation (blood gingival index)(After 14 days (t2))
- Plaque amount(After 14 days (t2))
研究者
研究点 (2)
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