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NCT01123330 · ClinicalTrials.gov registry record · Phase 2
Evaluation of a Brief Tailored Motivational Intervention to Prevent Early Childhood Caries
A Phase 2 study, sponsored by Temple University.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,042
- Enrollment target
NCT01123330: Completed Phase 2 study, sponsored by Temple University.
NCT01123330 is a Phase 2 study that has completed, run by Temple University. The registered enrollment target is 2,042 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1435% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01123330, a Phase 2 study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,042 participants
- Enrollment target
Study Summary
The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities within the community of low-income African-American children (0-5 years) and their main caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to identify determinants and design interventions to answer the following question: why do some low-income African-American children and their main caregivers have better oral health than others who live in the same community? The Project has 3 support cores, 4 research core projects and 1 pilot study. The Project has selected a multistage random sample of African-American families living in the poorest 39 Census Tracts in the City of Detroit. A total of 1,022 families were recruited and interviewed at a community center in Detroit during the year 2 (2002). We have collected data about the social characteristics of parents, families, and neighborhoods that are associated with disparities in oral health; lead levels in saliva and blood of the caregivers; and dietary intake. All these families will be recalled in the year 4 (2004) and year 6 (2006) for longitudinal data collection. We are currently developing a tailored multi-media educational intervention (Project #3), based on data collected in the first phase (2002). The educational intervention will be administered using a randomized controlled design in year 4 (2004). Additionally, the Project is evaluating the impact on access to dental care of a state-funded experiment on utilization where Medicaid children are managed like privately insured patients (Project #4).
Primary Outcome
The carious process was measured using the International Caries Detection and Assessment System (ICDAS). The codes range from measurement of the first visible carious change in enamel (Code 1) to extensive cavitation (Code 6). Both primary carious lesions and lesions adjacent to restorations and sealants (CARS) were recorded,.
Interventions
- BEHAVIORAL Motivational Interviewing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,042 participants |
| Start Date | 2001-10 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
What the finished NCT01123330 record still lists
NCT01123330 is an interventional study that assigns participants to a tested intervention. Its 2,042 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1435% higher).
The record links to 0 conditions, and to 1 intervention - of which Motivational Interviewing is the first listed.
NCT01123330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01123330 about?
NCT01123330 is a clinical study titled "Evaluation of a Brief Tailored Motivational Intervention to Prevent Early Childhood Caries". The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities within the community of low-income African-American children (0-5 years) and their main caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to identify determinants and d...
What is the current status of trial NCT01123330?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,042 participants. The study started on 2001-10. Estimated completion is 2007-10.
What interventions are being tested in trial NCT01123330?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL).
Who is sponsoring clinical trial NCT01123330?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01123330's enrollment target sits among peer trials
2,042 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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