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临床试验/NCT07539064
NCT07539064已完成不适用

Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs

Colgate Palmolive1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Claim Cost

研究概览

简要总结

The objective of this study is to demonstrate that compliance and brushing adherence as a treatment to providers, insurance company and State Health Departments that can help improve oral health of children who have already been treated for caries in the Operating Room. This would include reactions such as how easy and enjoyable the use of the toothbrush and app seemed to be for their child and how useful the caregiver found the connected toothbrush to be.

详细描述

Quantitative analysis of the claim cost and brush data analysis will be carried out, it will also involve creating descriptive summaries of the key themes that emerge during the interviews regarding the experiences of the patients and caregivers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Member of Blue Cross Blue Shield NJ.
  • Signed Informed Consent.
  • Parents/caregivers must have a child between the ages of 4-7 years old, who is willing to participate.
  • Parent/caregiver must reside with the child and be able to observe the child's use of the Colgate Connected kids toothbrush and Colgate Connect app.
  • Child and parent/caregiver must be in self-reported good general health and good oral health based on the opinion of the study investigator.
  • Parent/caregiver and child must be available for the duration of the study and be available to participate in the screening and other scheduled visits, as described below.
  • Access to Apple iPhone (newer than 6s) or iPad (newer than 5th generation) with access to an Internet Connection.

排除标准

  • Child has orthodontic appliances.
  • Child has obvious signs of oral disease or pain under the caregiver judgment.
  • Concurrent participation by child in another clinical study.

研究组 & 干预措施

Connected Toothbrush for Kids

This is a single-center, observational, non-randomized clinical study involving children in the Operating Room and analysis of the claim data after the Operating Room intervention and two subsequent years of use of the Colgate Connected kids toothbrush as well as lifestyle behavioral engagement intervention via text and Colgate Connect app according to compliance level, including goal oriented motivational messaging about oral Health, healthy eating, and looking to understand personal goals and challenges affecting the routine, participant activation measures , missed reasons ( AM/PM) by the child.

干预措施: Connected Toothbrush with a behavioral health intervention (Device)

结局指标

主要结局

Claim Cost

时间窗: 2 years

Quantitative analysis of the claim costs for the treatment group vs. the control group

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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