CompletedNot Applicable

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

United States93 participantsStarted 2023-03-04

Plain-language summary

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.

Who can participate

Age range

4 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Claim Cost

Timeframe: 2 years

Trial details

NCT IDNCT07539064

SponsorColgate Palmolive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-04

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