EVALUATING THE EFFICACY OF BLACK RAISIN TOOTHPASTE COMPARED TO SODIUM FLUORIDE TOOTHPASTE IN PREVENTING DENTAL CARES IN CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- The expected outcome of the study is to provide critical evidence regarding the efficacy of natural toothpaste in comparison to traditional fluoride-based commercial options. Specifically, the study will determine if the natural toothpaste can prevent dental caries as effectively as fluoride-based toothpaste, while also assessing secondary outcomes like plaque control, gingival health, safety, and user acceptability.
研究概览
简要总结
This study aims to evaluate the effectiveness of a newly developed natural toothpaste in preventing dental caries in children, compared to widely used commercial toothpaste products.
The research will focus on children aged 6 to 12, assessing key outcomes such as caries incidence, plaque control, and gum health over a 6-month period. Participants will be randomly assigned to one of two groups: the natural toothpaste, a fluoride-based commercial toothpaste. The study will include regular dental check-ups to monitor oral health and will provide participants with valuable insights into the potential benefits of natural oral care alternatives.
In addition to evaluating clinical outcomes, the study will explore the safety and tolerability of the natural toothpaste. The results could provide new evidence on the effectiveness of natural alternatives in children’s oral care, offering a safer or more sustainable option for families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 6 to 12 years.
- •2.No severe pre-existing dental conditions (e.g., severe dental caries, periodontal disease).
- •3.Parents or guardians must provide written consent for participation.
- •4.Children must not have any known allergies to any of the toothpaste ingredients.
排除标准
- •1.Children with severe dental conditions (e.g., advanced dental caries, need for orthodontic treatment).
- •2.Children on systemic medications that might influence oral health (e.g., immunosuppressants).
- •3.Children who are already enrolled in another clinical trial or using a specialized oral health product.
结局指标
主要结局
The expected outcome of the study is to provide critical evidence regarding the efficacy of natural toothpaste in comparison to traditional fluoride-based commercial options. Specifically, the study will determine if the natural toothpaste can prevent dental caries as effectively as fluoride-based toothpaste, while also assessing secondary outcomes like plaque control, gingival health, safety, and user acceptability.
时间窗: 6months
次要结局
- To improve overall oral health of children(6months)
研究者
Dr VVNKarthik
Saveetha Medical College and Hospital