Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
研究概览
简要总结
The study is randomized controlled trial ... The null hypothesis of the present study is that there is no antibacterial efficacy of gold nanoparticles of pelargonium graveolens mouthwash against Streptococcus mutans and Candida Albicans . Meanwhile the alternative hypothesis of the present study is that gold nanoparticles of pelargonium graveolens mouthwash have antimicrobial activity against Streptococcus mutans and Candida Albicans .
详细描述
This is double blind study will be conducted among male patients with mild to moderate gingivitis . Those patients aged between (7-14 ) years old who attended the second specialized dental health center in Baquba city/ Diyala governorate/ Iraq. patients will be randomly assigned to one of two study groups the first group is Gold Nano particle from Pelargonium Graveolens Mouthwash , the second Chlorhexidine. by using 15ml of it for one minute two times daily for three weeks. In this study a clinical parameters as ( plaque index, gingival index and calculus index ) were assessed at the base line (before mouthwash use), and then assessed three times at one week interval after the base line assessment through the period of mouthwash use. On the other hand, microbiological aspect were assessed for those patients before and three weeks after the use of Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine . After three weeks the mean of plaque, gingival, and culculs indices are significantly reduced after the use of Biogenic Gold Nano particle from Pelargonium Graveolens Leaves Extract Mouthwash.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Single (participant)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The study sample will include a group if children aged (7-14) years, with mild to moderate crowding, attending the specialist dental center in Diyala city.
- •Patients with mild to moderate gingivitis as a base line (for standardization).
- •Healthy child without any oral ulceration or systemic medical condition.
- •Cooperative child.
- •Patient did not take any antibiotics or anti-fungal for at least 4 weeks prior to sampling procedure.
- •Children are healthy without any systemic disease .
- •From the same geographical area ( Diyala Governorate ).
排除标准
- •Children outside specified age.
- •Children with systemic disease or on medication.
- •Children on a daily fluoride or other therapeutic regimen were excluded from the study.
- •Children 's parents who are smokers (passive smoking ) to reduce the confounding factors.
- •No more than one child per family to be allowed into the study.
- •Children who their parents refuse to participate in the study.
研究组 & 干预措施
Gold Nano particle from Pelargonium Graveolens Mouthwash group
Gold Nano particle from Pelargonium Graveolens Mouthwash will be applied as a mouthwash for three weeks and then follow up .
干预措施: Gold Nano particle from Pelargonium Graveolens Mouthwash (Drug)
Chlorhexidine gluconate mouth wash group
Chlorhexidine gluconate mouth wash will be applied as a mouthwash for three weeks and then follow up .
干预措施: Chlorhexidine gluconate mouthwash . (Drug)
结局指标
主要结局
The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
时间窗: 3 weeks after mouth wash application
The measure will be done using international detection and assessment criteria for diagnosing mild to moderate gingivitis by naked eye and periodantal probe.
次要结局
未报告次要终点
研究者
Ahmed Yousif Mahdi
Principal Investigator
University of Baghdad