Caries ActiveNCT07539064
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
An observational study of Caries Active and Prevention, run by Colgate Palmolive at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Caries Active, Prevention
- What is being tested?
- Connected Toothbrush with a behavioral health intervention
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2023to 15 Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Kids between 4-7 years old that are schedule for Oral Health treatment in the Operating Room, we will follow cohort Claims related to the use of the Colgate Connected toothbrush \& behavioral health intervention
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dentistry for Children, 870 River Avenue
Lakewood, New Jersey, 08701
About this study
Official title: Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs
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.
Read the detailed description
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.
- Conditions
- Caries Active, Prevention
- Being tested
- Connected Toothbrush with a behavioral health intervention
- Keywords
- claim cost, prevention, connected toothbrushes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected Toothbrush with a behavioral health interventionDevice
Also called connected toothbrush, behavioral health
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Connected Toothbrush with a behavioral health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Claim Cost
Quantitative analysis of the claim costs for the treatment group vs. the control group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start4 Mar 2023
- Primary completion4 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ActiveStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matilde Hernandez Clinical research, DDS, Study director, Colgate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539064
- Sponsor's protocol ID
- CRO-2022-HUM-BCBS-MH-SG
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids That go Thru Operating Room Will be Given a Connected Health Toothbrush, Kids Anticavity Toothpaste and Behavioral Health Intervention to Reduce Claim Costs
- ClinicalTrials.gov ID
- NCT07539064
- Acronym / sponsor ID
- CRO-2022-HUM-BCBS-MH-SG
- Conditions
- Caries Active, Prevention
- Keywords
- claim cost, prevention, connected toothbrushes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Connected Toothbrush for Kids | – | Device: Connected Toothbrush with a behavioral health interventionThis 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Kids between 4-7 years old that are schedule for Oral Health treatment in the Operating Room, we will follow cohort Claims related to the use of the Colgate Connected toothbrush \& behavioral health intervention
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connected Toothbrush with a behavioral health interventionAlso: connected toothbrush, behavioral healthColgate 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. | Device | Connected Toothbrush for Kids |
Primary outcome
Claim Cost
Time frame: 2 years
Quantitative analysis of the claim costs for the treatment group vs. the control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matilde Hernandez Clinical research, DDS study director
Colgate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries Active and Prevention, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Claim Cost (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.