CSM theory-based Arm for Dental Caries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dental Caries
Practice EMR changes - Other
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will address poor dental utilization (attendance) and untreated caries among 3-6 year old Medicaid-enrolled children attending well-child visits (WCV) in primary care settings. The focus is on addressing factors (determinants) at the socio-ecological levels of the child's environment: provider (pediatrician and nurse practitioner), practice/organization level, and parent/caregiver level.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit:WCV#3)

Month 24
Change in oral health-related quality of life
Change in oral hygiene
Month 24
Change in diet
Month 24
Direct and indirect dental costs
Month 24
Dental Attendance
Month 24
Change in primary and permanent decayed and filled teeth

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

AAP-based Arm
1 of 2
CSM theory-based Arm
1 of 2
Active Control
Experimental Treatment

2111 Total Participants · 2 Treatment Groups

Primary Treatment: CSM theory-based Arm · No Placebo Group · N/A

CSM theory-based ArmExperimental Group · 2 Interventions: Practice EMR changes, CSM theory-based didactic education and skills training · Intervention Types: Other, Behavioral
AAP-based Arm
Other
ActiveComparator Group · 1 Intervention: AAP-based didactic education · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed as change between baseline well-child visit (wcv #1) and 24 month follow-up exit visit (well-child visit:wcv#3)

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
274 Previous Clinical Trials
196,244 Total Patients Enrolled
3 Trials studying Dental Caries
2,457 Patients Enrolled for Dental Caries
National Institute of Dental and Craniofacial Research (NIDCR)NIH
281 Previous Clinical Trials
803,028 Total Patients Enrolled
37 Trials studying Dental Caries
47,977 Patients Enrolled for Dental Caries
Suchitra Nelson, PhDPrincipal InvestigatorCase Western Reserve University
2 Previous Clinical Trials
1,867 Total Patients Enrolled
2 Trials studying Dental Caries
1,867 Patients Enrolled for Dental Caries

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Legal guardianship of children who are enrolled in Medicaid and who are aged 3-6 years and who are attending a well-child visit (WCV) is necessary in order to ensure that the children receive the necessary care.
The patient should provide a signed and dated consent form to indicate that they are aware of the risks and benefits of the procedure and are willing to undergo it.
The text is about someone who is enrolled in Medicaid
At least 20% of pediatric patients should be covered by Medicaid.
A pediatrician or nurse practitioner is needed who can provide patient care at least two days per week.
The person must be at least 18 years old.
You can speak English or Spanish in this restaurant.
will maximize the benefits of the early years program If you want your child to reap the benefits of early childhood education, it's important to stay in the same area for at least two years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.