NCT07220850: PROTECT

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

Recruiting now NA Last updated 7 May 2026

What this trial tests

NA trial testing Behavioral Treatment in Early Childhood Caries in 420 participants. Currently enrolling.

Timeline

30 September 2025

Primary endpoint
1 September 2027

1 September 2028

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	420
Start date	30 September 2025
Primary completion	1 September 2027
Estimated completion	1 September 2028
Sites	1 location across United States

Drugs / interventions tested

• Behavioral Treatment — full drug profile →

Conditions studied

• Early Childhood Caries — all drugs for Early Childhood Caries →

Sponsor

University of Illinois at Chicago

Who can join

Under 7, any sex, with Early Childhood Caries. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Basic Research Factors Questionnaire (BRFQ)
  Time frame: 12 months; from baseline to 12 months post-surgical event (assessments at baseline, 6 months and 12 months)
  Child and caregiver brushing behaviors (11 items) are included in the Basic Research Factors Questionnaire (BRFQ). The BRFQ is a validated questionnaire to assess dental knowledge, attitudes, and behaviors of caregivers with young children. We will also assess frequency of brushing, assistance with brushing, and use of fluoridated toothpaste. The BRFQ is validated in English and has been translate
• Child's dietary intake from the previous day (12:00A - 11:59P) will be captured in-person/telephone/zoom using Nutrition Data System for Research (NDSR) data capture and analysis software
  Time frame: 12 months: from baseline to 12 months post-surgical event. Assessments are at baseline, 6 months and 12 months.
  The software uses interview prompts to conduct a standardized multiple pass 24-hour dietary recall. The multi-pass approach enables respondents to recall foods and beverages consumed with greater accuracy. The parent/caregiver will be asked to use the food amounts booklet to aid the diet interview. A bilingual team member will use the Spanish interviewer prompts provided as an option in the NDSR s

Sponsor's own description

Too many young children, particularly those living in poverty, present for dental surgery under anesthesia - an expensive, potentially dangerous, short-term fix that often results in recurring oral health disease and subsequent surgeries. Dr. Helen Lee, an anesthesiologist, and Dr. Joanna Buscemi, a clinical health psychologist, recognized that to decrease need for surgeries, caregivers need resources and support to build their skills and knowledge around managing their child's oral health. After 5 years of relationship-building, publishing preliminary qualitative work, and building a team with the appropriate skills and knowledge, investigators developed a grant application to develop and test a parenting intervention for caregivers of preschool- aged children presenting for dental surgery.

With support from the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH), the team created the PROTECT intervention with a focus on providing caregivers with parenting and behavioral tools to help improve tooth brushing and lower added sugar intake while simultaneously addressing social determinants of health that make behavior change more difficult. Community health workers will engage with caregivers for 6 months following the child's surgery to deliver PROTECT and support parents in behavioral change. A surgical event is a unique opportunity to change behaviors in systemically oppressed families that have manifested a need for behavior change. This intervention will meet caregivers needs at a critical time when risk disease recurrence intersects with a desire to change. This work has the potential to not only improve oral health of entire households but may also have a concomitant effect on parallel diseases, such as pediatric obesity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.