Helping caregivers prevent repeat dental surgery for preschool children with severe tooth decay
Official title: Testing a Multi-behavioral Intervention to Improve Oral Health Behaviors in the Pediatric Dental Surgery Population
Run by University of Illinois Chicago · NCT07220850 · Data updated 2026-11-12
This program tests whether giving caregivers skills and support can help preschool children who need dental surgery avoid repeat cavities and future surgeries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 7 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | University of Illinois Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2028 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07220850 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are caregivers aged 18–90 who live with a preschool-aged child (<96 months) scheduled for dental surgery at the UIC clinic and who can use a phone or computer.
✕Probably not a fit
Children in foster care, those with significant medical complexity (ASA ≥3) or developmental disorders, families planning to move out of state within six months, and adults unable to consent are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PROTECT intervention provides parenting skills, education, and support to caregivers of preschool children scheduled for dental surgery under general anesthesia for severe early childhood caries. Eligible caregivers are 18–90 years old, live with the child at least half the time, have phone or computer access, and the child must be under 96 months and scheduled for surgery at the UIC clinic. The intervention uses behavioral strategies delivered through community-health-worker–supported contacts and remote or clinic-based sessions to improve toothbrushing, diet, and caregiver monitoring. Trial outcomes include recurrence of caries, need for repeat dental surgery, and caregiver- and child-centered oral health behavior measures.
Why it matters
Potential benefit: If successful, the intervention could lower the risk of recurrent severe cavities and reduce the need for repeat dental surgery in young children.
How similar studies have gone: Behavioral parenting interventions have improved child health behaviors in other areas, but interventions specifically designed to prevent recurrence of severe early childhood caries after dental surgery are limited and this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * caregivers of child patients who are in the same household greater than or equal to 50% of the week * caregivers aged 18-90 years * caregivers with access to a computer or a telephone * child patients that are less than 96 months of age at the time of enrollment scheduled for DGA at the UIC clinic Exclusion Criteria: * surgical child is foster status * families who are planning to move out of state within the six-month period * children with systemic health issues as classified by American Society of Anesthesiology Classification of greater than or equal to 3, or a mental health condition such as autism/developmental delay, as medical complexity is associated with other issues that influence a child's health behaviors and caregiver-child interactions * and adults unable to consent.
Where it's running
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College of Dentistry (MC 621)
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Helen Lee, MD, MPH — University of Illinois Chicago
- Study coordinator: Helen Lee, MD, MPH
- Email: leehelen@uic.edu
- Phone: 312-996-4020
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.