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

NCT07539064 | Completed DMC FDA Device

• 1 other identifier: CRO-2022-HUM-BCBS-MH-SG
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caries Active; Prevention

Keywords

claim cost; prevention; connected toothbrushes

Outcome Measures

Primary Outcomes (1)

• Claim Cost

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

  2 years

Study Arms (1)

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.

Device: Connected Toothbrush with a behavioral health intervention

Interventions

Connected Toothbrush with a behavioral health intervention DEVICE

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.

Also known as: connected toothbrush, behavioral health

Connected Toothbrush for Kids

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Dentistry for Children, 870 River Avenue

Lakewood, New Jersey, 08701, United States

Location

Study Officials

• Matilde Hernandez Clinical research, DDS

  Colgate

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: April 20, 2026
• Study Start: March 4, 2023
• Primary Completion: March 4, 2025
• Study Completion: June 15, 2025
• Last Updated: April 20, 2026

Record last verified: 2025-01

Locations

US (1)