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临床试验/CTRI/2025/08/092295
CTRI/2025/08/092295尚未招募不适用

Exploring the role of a novel color – changing toothpaste as an aid for improving children’s oral hygiene behavior: an in vivo study

Star Dental Care Private Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1- Improved brushing techniques: Children using the color changing toothpaste are expected to show better plaque removal

研究概览

简要总结

Maintaining sound oral health, particularly in children, is essential, as poor oral hygiene can lead to a myriad of dental issues, including early childhood caries. However, many children struggle with developing consistent and effective brushing habits, often due to lack of motivation, poor comprehension of brushing techniques, and the monotony of the chore. Ensuring children adopt and maintain proper oral hygiene practices is a significant challenge for parents, caregivers and healthcare professionals. An innovative approach to improving children’s oral hygiene behaviors is by using a colour changing toothpaste. This product is designed to provide visual feedback during brushing by changing colour to purple after two minutes of brushing. This colour change helps children to identify that the brushing time is complete. The theory behind a colourchanging toothpaste is that it visually highlights the time needed to complete toothbrushing. By incorporating a fun, interactive element into the oral hygiene routine, the colour changing toothpaste could increase children’s engagement, making brushing a more exciting and rewarding experience. There is sparse scientific evidence exploring the true effectiveness of this novel toothpaste to improving children’s brushing technique, motivating them to brush regularly thereby reducing plaque buildup. While evidence suggests that children may find such products engaging, there has been little rigorous research to assess their potential to enhance oral hygiene behaviors systematically. This study aims to fill this gap by investigating the role of color changing toothpaste in influencing children’s oral hygiene behaviors, specifically focusing on the following key areas: Improvement in brushing technique, Increased motivation, Long term oral hygiene habits

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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- Healthy children with no systemic or medical conditions that would interfere with the study 2- Parents/ caretakers who consent to their child’s participation in the study 3- Children able to brush independently 4- Children not undergoing any orthodontic treatment.

排除标准

  • 1- Children with a history of allergic reactions to toothpaste ingredients 2- Children who have received extensive dental treatments during the study period.

结局指标

主要结局

1- Improved brushing techniques: Children using the color changing toothpaste are expected to show better plaque removal

时间窗: BASELINE, WEEK5, WEEK10

2- Increased motivation: The colour changing feature is anticipated to make brushing more engaging and motivate children to brush consistently

时间窗: BASELINE, WEEK5, WEEK10

3- Enhanced long term oral hygiene: We presume that the experimental group will maintain better oral hygiene habits over time, leading to improved oral health outcomes

时间窗: BASELINE, WEEK5, WEEK10

次要结局

  • Brushing Frequency & Duration:(Self-reported brushing logs maintained by children/parents to monitor frequency (twice a day adherence) & brushing duration.)

研究者

发起方
Star Dental Care Private Limited
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Nithya Annie Thomas

Manipal Academy of Higher Education

研究点 (1)

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