NCT03166163Unknown不适用
Evaluation of Bleeding on Brushing Among a Group of Egyptian Children After Using Azadirachta Indica (Neem Extract)Mouthwash Versus Chlorhexidine Mouthwash: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Bleeding on brushing
研究概览
简要总结
i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.
详细描述
- First , we will select the patients according to the inclusion criteria.
- We will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. The scoring is ranging around eight anterior teeth from 0 to 5.In this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability.
- 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control.
- Chlorhexidine will be coded with the letter "A" and the mouthwash of 2%neem extract with the letter "B".
- The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "A" and "B"
- The intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO probe. All materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards.
- The rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. Kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results.
- After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.
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
- Double (Participant, Investigator)
盲法说明
This was a double -blind study as the investigator was unaware about the sampling of the groups and study subjects were unaware about the mouthwash they were using
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 8-10 years old with gingivitis
- •cooperative children
- •3.both genders
- •4.medically free
- •sulcus bleeding index score is 2
排除标准
- •Children undergoing orthodontic treatment
- •2.Children undergoing any other oral hygiene aid other than routine teeth brushing
- •3.Children with known history of allergy to any mouthwash or drug
- •4.Parents unable to give informed consent
- •5.Children taking antibiotic or antiseptic in previous two months
研究组 & 干预措施
Azadirachta indica (Neem extract)
Experimental
its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks
干预措施: Azadirachta indica (Drug)
chlorhexidine mouthwash
Active Comparator
its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks
干预措施: Chlorhexidine mouthwash (Drug)
结局指标
主要结局
Bleeding on brushing
时间窗: 3 weeks
measuring device(asking the patient) measuring unit (binary)
次要结局
- sulcus bleeding index(3 weeks)
研究者
Samar Sherif Ali Mostafa
Master dental student, pediatric dentistry department.
Cairo University
研究点 (1)
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