Efficacy of dantaraksha toothpaste in comparison to pediflor kidz toothpaste in prevention of krimidanta, early childhood caries- a double blind randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in clinical features in Krimidanta, dental caries and improvement in oral hygiene
研究概览
简要总结
Efficacy of dantaraksha toothpaste in comparison to pediflor kidz toothpaste in prevention of Krimidanta, early childhood caries - a double blind randomized controlled clinical trial. In my study I have taken 2 groups Group 1 is of trail drug Dantaraksha toothpaste and Group 2 is of control group Pediflor kidz toothpaste. Medicinine will be selected by computer cheat methods. Here both the participant and investigator will be blind only guide will know the drug which is selected. Duration of the study is for 45 days and after 15 days follow up will be their Methodology is Interventional (clinical) For study group: 3 to 6 years old children with the manifestation of Krimidanta, Early Childhood caries attending Kaumarabhritya outpatient department and in patient department of Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru.For control group: 3 to 6 years old children with the manifestation of Krimidanta, Early Childhood Caries attending Kaumarabhritya outpatient department and in patient department of Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children of age group 3-6 years of either sex presenting with Krimidanta, Dental caries with two or more symptoms mentioned under diagnostic criteria will be included in the study.
- •2.Parents willing to participate their kid and ready to sign assent/ consent form.
排除标准
- •1.Children with advanced periodontal disease.
- •2.Children using orthodontic appliances.
- •3.Use of antibiotics for a dental cause in last 1month.
- •4.Children on mouth rinses for the last 3 months.
- •5.Children having other diseases of oral cavity.
- •Children allergic to tooth paste.
结局指标
主要结局
Reduction in clinical features in Krimidanta, dental caries and improvement in oral hygiene
时间窗: At baseline, 15th day, 30th day and 45th day
次要结局
- Identify risk factors for dental caries.
研究者
Dr Kalambe Darshan Dinkar
SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore