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

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.

Study Overview

• Status: Completed
• Conditions: Prevention; Caries Active
• Intervention / Treatment: Device: Connected Toothbrush with a behavioral health intervention

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Lakewood, New Jersey, United States, 08701
      • Dentistry for Children, 870 River Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: connected toothbrush; behavioral health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Claim Cost	Quantitative analysis of the claim costs for the treatment group vs. the control group	2 years

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Matilde Hernandez Clinical research, DDS, Colgate

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2023
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prevention; claim cost; connected toothbrushes
• Other Study ID Numbers: CRO-2022-HUM-BCBS-MH-SG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No