Adults 3 to 6, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dental AttendancePrimary· Data will be abstracted from Clinical Exams and Medicaid Claims data at baseline and the exit visit at the 24 month follow-up visit.
Receipt of any dental care (preventive and/or restorative) at approximately 24 months from baseline to the exit visit. Any dental care was defined as yes or no visit.
Medicaid Claims Data
Group
Value
95% CI
CSM Theory-based Arm
330
AAP-based Arm
332
Clinical Examination Data
Group
Value
95% CI
CSM Theory-based Arm
170
AAP-based Arm
150
Change in Primary Decayed and Filled TeethSecondary· Dental exams will assess change in dft between baseline well-child visit (WCV#1) and 24 month follow-up exit visit (well-child visit: WCV#3)
dft: number of decayed, missing and filled teeth (dft) at WCV#3 minus the number at WCV#1.
Group
Value
95% CI
CSM Theory-based Arm
1.14
± 2.45
AAP-based Arm
1.16
± 2.34
Change in Oral Hygiene-brushingSecondary· Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)
Change in mean number of times per day a child in the study brushed.
Group
Value
95% CI
CSM Theory-based Arm
-0.01
± 0.63
AAP-based Arm
-0.04
± 0.62
Change in DietSecondary· Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit:WCV#3)
Number of sugar-sweetened drinks consumed per day
Group
Value
95% CI
CSM Theory-based Arm
0.01
± 0.88
AAP-based Arm
0.04
± 0.94
Change in Oral Health-related Quality of Life for ChildSecondary· Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)
Overall score on Early Childhood Oral Health Impact (ECOHIS) Scale with 13 items. Each item is on a Likert scale from 0 through 4. The overall score ranges from 0 to 52. An overall score was calculated for each child, and then a mean calculated for each arm of the study. Lower scores indicate a better oral health quality of life.
Group
Value
95% CI
CSM Theory-based Arm
0.56
± 3.38
AAP-based Arm
0.50
± 3.42
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3)..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study is a multi-site, multi-level, and multi-component cluster randomized clinical trial (RCT) to 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. Eighteen practices will be randomized to 2 arms: A) bundled multi-level intervention consisting of: 1. training medical providers in the Common-Sense Model of Self-Regulation theory-based education so that the provider delivers to the parent/caregiver the following: i) Core oral health facts about dental caries, and ii) prescription to visit the dentist and a list of dentists accepting Medicaid; 2. Integration of oral health assessments into EMR for the provider to document in the child's medical record; versus B) Control arm of medical providers receiving the American Academy of Pediatrics (AAP) based oral health education and providing usual AAP-based care for oral health. Each arm will consist of 9 practices. Children will be followed for 24 months to determine dental utilization and changes in oral health status.
The primary aim is to examine the effectiveness of theory-based behavioral (provider-level) and implementation (practice-level) bundled interventions versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs in increasing dental attendance among 3-6 year old Medicaid-enrolled children. The secondary aims are to 1) assess the effectiveness of interventions on secondary outcomes (e.g. development of new caries, changes in oral hygiene, oral health quality of life, frequency of sweet snacks and beverages, cost), 2) assess potential mediators and moderators to investigate the pathways through which the multi-level interventions affect child primary and secondary outcomes, and 3) assess the adoption, reach, fidelity, and maintenance of providers and practices that affect child primary and secondary outcomes.
The hypothesis is that theory-based behavioral (provider-level) and implementation (practice-level) bundled interventions delivered by providers at WCVs will increase dental attendance among 3-6 year old Medicaid-enrolled children versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Case Western Reserve University
Last refreshed: 17 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03385629.