Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Difference in the Gingival Index scores.
研究概览
简要总结
The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.
详细描述
In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group: 09-12 years old
- •Presence of at least 20 teeth
- •Simplified Oral Hygiene Index (S-OHI)≥ 1,6
排除标准
- •Use of orthodontic appliance
- •Recent (in the past 2 months)use of antibiotics and mouthwashes
研究组 & 干预措施
Punica granatum Linn.
The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.
干预措施: Punica granatum Linn. (Drug)
chlorhexidine
The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.
干预措施: chlorhexidine (Drug)
结局指标
主要结局
Difference in the Gingival Index scores.
时间窗: Baseline, Seventh Day and Fourteeth day (14 days)
On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.
Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.
时间窗: Baseline and Fourteeth day (14 days)
At baseline, we collected non-stimulated saliva samples into a sterile container for counting of oral streptococci in the laboratory. And on the fourteenth day, we carried out the second saliva collection and measured the clinical indices used.
Difference in the Gingival Bleeding Index scores.
时间窗: Baseline, Seventh Day andFourteeth day (14 days)
On day 0, we measured the Bleeding on Probing Index (BPI) (Ainamo; Bay, 1975) at baseline, on the seventh day and on the fourteenth day.
次要结局
未报告次要终点
研究者
DANÚBIA ROBERTA DE MEDEIROS NÓBREGA
Professor clinical
Universidade Estadual da Paraiba