Assessing Child And Parental Acceptability: A Double-Blind Randomized Clinical Trial Comparing Two Toothpaste Brands Among Children Aged 3-6 Years
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.This study will shows the toothpaste acceptability, particularly in terms of taste, color and oral care needs, plays a key role in encouraging proper brushing habits in children.
研究概览
简要总结
This study aims to compare two toothpaste brands among children aged 3-6 years, focusing on child and parental acceptability. The objectives include assessing children’s acceptability based on taste, texture, and color, and evaluating parental satisfaction regarding effectiveness and preference.
The study is conducted at the Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College, involving 60 children who meet specific inclusion criteria. Children are randomly divided into two groups to use either Pediflor Kidz (Green Apple) or Kids Bunny (Strawberry) toothpaste. A double-blind, randomized clinical trial design ensures neither the participants nor the examiners know the toothpaste brands during the study.
Parents provide informed consent, and children and parents follow specific brushing instructions. After four weeks of use, parents complete a questionnaire assessing the toothpaste based on factors like taste, texture, and overall satisfaction.
Data is collected before, during, and after the trial, including oral health status, adverse events, and feedback on both the child’s and parent’s experiences. The study aims to provide insights into preferences for pediatric toothpaste, guiding future product recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Children aged 3-6 years and their parents/guardians willing to participate in the study.
- •Children with no medical condition or allergy.
- •Children who can cooperate.
排除标准
- •History of antibiotic use in the last 2 weeks
- •Those using mouth rinses containing chemical agents or inter-dental cleaning aids regularly.
- •Children with congenital anomalies, physical or mental disabilities
- •Children with known allergies or sensitivities to ingredients in the toothpaste brands being tested.
结局指标
主要结局
1.This study will shows the toothpaste acceptability, particularly in terms of taste, color and oral care needs, plays a key role in encouraging proper brushing habits in children.
时间窗: 6 months
次要结局
- 2. By considering child & parental preferences, toothpaste manufacturers can improve product compliance & support better oral health in children
研究者
Dr Shilpa Kochar
Chhattisgarh Dental College & Research Institute