Actively Recruiting

Phase Not Applicable
Age: 0 - 7Years
All Genders
ID07220850

Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population

Led by University of Illinois at Chicago · Updated on 2026-05-08

420

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve oral health behaviors in preschool-aged children who are undergoing dental surgery under general anesthesia due to severe early childhood caries (S-ECC). The study recognizes that many young children, especially those in underserved communities, face recurring oral health problems despite surgery. By focusing on caregivers, the study addresses behavioral factors such as tooth brushing and sugar intake that contribute to caries and its recurrence. The intervention also considers social challenges that affect families' ability to make lasting changes. The study evaluates a 6-month behavioral parenting program called PROTECT, which is delivered by community health workers to caregivers of children scheduled for dental surgery. PROTECT includes 10 sessions that focus on improving tooth brushing habits, reducing added sugar consumption, promoting positive parenting, goal setting, stress management, and problem-solving. The program supports families by connecting them to social services when needed and is compared to usual clinical care, which includes standard education provided around the time of surgery. Participants will be involved in the study for 12 months, starting at the surgical event, with assessments at baseline, 6 months, and 12 months. Data collected includes caregiver and child questionnaires about oral health behaviors, dietary intake, parenting practices, and clinical dental health indicators. Weekly remote assessments via text messaging will track parental behaviors and barriers. The study monitors adherence to the intervention and measures changes in tooth brushing frequency and sugar intake as primary outcomes, with additional evaluations of parenting and dental health status.

CONDITIONS

Brief Title

Oral Health Intervention for Caregivers of Children Presenting for Dental Surgery

Who Can Participate

Age: 0 - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers who live with the child patient at least 50% of the week
  • Caregivers aged between 18 and 90 years
  • Caregivers with access to a computer or telephone
  • Child patients younger than 96 months (8 years) at enrollment scheduled for dental surgery under general anesthesia at the study clinic
Not Eligible

You will not qualify if you...

  • Child patients in foster care
  • Families planning to move out of state during the 6-month study period
  • Children with significant systemic health issues (ASA Classification 3 or higher) or mental health conditions like autism or developmental delay
  • Adults unable to give consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility prior to surgery

Treatment

Duration - 6 months

Participants receive the PROTECT behavioral parenting intervention over six months starting at the dental surgery event. This program includes 10 sessions focused on improving children's toothbrushing frequency and reducing sugar intake, delivered by community health workers.

10 sessions delivered by community health workers over 6 months

Follow-up

Duration - 6 months

Participants are assessed for oral health behaviors and outcomes for 6 months after completing the intervention to evaluate lasting effects.

Assessments at 6 and 12 months post-surgery

Trial Site Locations

Total: 1 location

1

College of Dentistry (MC 621)

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

H

Helen Lee, MD, MPH

J

Joanna Buscemi, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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