Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
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
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
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
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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