Behavioral Treatment for Early Childhood Caries

(PROTECT Trial)

Overseen By Joanna Buscemi, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Foster status, Moving, Systemic health issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 6 months

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of young children improve their kids' oral health and reduce the need for repeat dental surgeries. It focuses on teaching parents effective tooth brushing habits and reducing sugar intake, along with providing support in parenting and stress management. The PROTECT program involves working with community health workers for six months after surgery to guide behavior change. Families with children scheduled for dental surgery and who live together most of the time are well-suited for this trial. As an unphased trial, this study offers families the chance to participate in innovative research that could significantly enhance children's oral health and overall well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on providing support for managing children's oral health, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that the PROTECT intervention is safe for children and caregivers?

Research has shown that the PROTECT program safely manages early childhood tooth decay by promoting healthy habits. This program helps caregivers enhance their children's toothbrushing routines and reduce sugar intake, while also providing support in parenting and stress management.

Studies have found that the program emphasizes teaching and support rather than medication or surgery, resulting in very low risk for participants. Similar programs focusing on education and behavior change have reported no major problems.

As a non-invasive and supportive program, PROTECT is considered easy to manage. Participants engage with community health workers in sessions designed to foster healthy habits without any known risks, making it a safe option for improving a child's oral health through lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PROTECT is unique because it combines behavioral strategies with direct caregiver engagement to tackle early childhood caries. Unlike standard treatments that focus primarily on clinical care and education during dental visits, PROTECT offers a comprehensive 6-month parenting program that addresses toothbrushing and sugar intake, alongside broader parenting skills and stress management. Researchers are excited about this approach because it empowers caregivers with actionable strategies and continuous support from community health workers, potentially leading to lasting changes in oral health behaviors and reducing the recurrence of dental issues in children.

What evidence suggests that the PROTECT intervention is effective for early childhood caries?

Research has shown that the PROTECT program, available to participants in this trial, can enhance children's oral health by teaching caregivers effective parenting techniques. The program emphasizes increasing tooth brushing and reducing sugar intake, both of which prevent cavities. Studies have found that similar programs improve oral health by encouraging positive behavior changes. Early results suggest that support from community health workers facilitates these changes for families. Overall, the program aims to reduce the need for future dental surgeries by addressing habits that lead to tooth decay. ^{3 4 6 7 8}

Who Is on the Research Team?

Helen Lee, MD, MPH

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for caregivers of preschool-aged children who are undergoing dental surgery due to Early Childhood Caries. It's aimed at those who may need extra support and resources to manage their child's oral health, particularly families living in poverty.

Inclusion Criteria

I am a caregiver to a child patient and live with them more than half the week.

I am a caregiver aged between 18 and 90.

Caregivers with access to a computer or a telephone

Exclusion Criteria

Surgical child is foster status

Families who are planning to move out of state within the six-month period

My child has a serious health or mental health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Event

Children undergo dental surgery under general anesthesia

1 day

1 visit (in-person)

Treatment

PROTECT intervention delivered by community health workers to caregivers over 6 months

6 months

10 sessions (5 informational, 5 maintenance)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at baseline, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PROTECT

Trial Overview The PROTECT intervention is being tested, which provides parenting and behavioral tools to help caregivers improve their child’s tooth brushing habits and reduce sugar intake. Community health workers will assist families for 6 months post-surgery.

How Is the Trial Designed?

Group I: PROTECT Arm: This is the behavioral intervention arm Experimental Treatment 1 Intervention

PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment) is a 6-month parenting program using evidence-based strategies to increase children's toothbrushing and reduce sugar intake. Sessions also address positive parenting, goal setting, stress management, and problem-solving. Community health workers (CHWs)-some bilingual in Spanish-will deliver 10 sessions (5 informational, 5 maintenance) to caregivers of children scheduled for dental surgery at UIC. Each 30-60-minute session focuses on applying skills to daily life and overcoming behavior-change challenges. CHWs can connect caregivers to social services or dental providers and refer concerns to a clinic social worker through a clinical psychologist. The program, developed from prior evidence and oral health/CHW curricula, covers oral health, nutrition, parenting, rewards, routines, problem-solving, monitoring, self-efficacy, and goal setting.

Group II: Usual Care: Control Active Control 1 Intervention

The control, or Usual Care (UC) group will receive usual clinical care, which consists of education during and immediately after surgery. Families randomized to the UC arm will receive the usual standard of care between the time they are identified as surgical candidates to the point when they are scheduled to have their post-surgical visit. Clinical education is provided by pediatric dental residents, and at least one pre-surgical visit is designed to allow families to discuss how their oral health behaviors contribute to caries and answer any questions regarding changing oral health behaviors. Families who are experiencing significant social issues which interfere with their ability to care for their child's teeth are identified by clinic staff and referred to a full-time social worker employed by the dental clinic. Similar to the intervention arm participants, RAs will be trained to report any potential social issues to the research team's clinical psychologist for referral.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Citations

1. dentistry.uic.edu dentistry.uic.edu/protect-research-study/

PROTECT Research Study | University of Illinois Chicago A grant application to develop and test a parenting intervention for caregivers of preschool- aged children presenting for dental surgery.

2. reporter.nih.gov reporter.nih.gov/project-details/11139943

Testing a Multi-behavioral Intervention to Improve Oral Health ... The current study aims to develop and test the initial efficacy of PROTECT (Preventing Recurrent Operations Targeting Early Childhood Caries Treatment), a 6- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07220850

Oral Health Intervention for Caregivers of Children ... The objective of this study is to develop and test the initial efficacy of PROTECT (Preventing Recurrent Operations Targeting Early Childhood ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39931301/

Testing a multi-behavioral intervention to improve oral health ... This study aims to test the efficacy of the PROTECT intervention compared to Usual Care (UC), to improve behavioral oral health outcomes.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1488910/full

Testing a multi-behavioral intervention to improve oral ... This study aims to test the efficacy of the PROTECT intervention compared to Usual Care (UC), to improve behavioral oral health outcomes.

6. cdc.gov cdc.gov/pcd/issues/2025/24_0151.htm

Chronic Disease Management of Early Childhood Dental ... Data collected included treatment approaches, time allocated to counseling, and personal, practice, and patient population characteristics.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289954/

Behavioral Outcomes of a Pragmatic Early Childhood Caries ... Abstract. Objectives: To evaluate a preventative behavioral intervention for managing early childhood caries (ECC) in a cohort of high-risk children.

8. aapd.org aapd.org/globalassets/media/policies_guidelines/p_eccconsequences.pdf

Policy on Early Childhood Caries (ECC) The recommended professionally-applied fluoride treatment for children at risk for ECC who are younger than 6 years is 5% sodium fluoride varnish (NaFV; 22,500 ...