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Birth to Three - Cavity Free
NCT05756413 · View on ClinicalTrials.gov ↗
Study Summary
Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the disease burden. The likelihood of parents of high-ECC risk young children seeking prevention in dental facilities is low; therefore, there is a need to increase preventive dental opportunities where these children already seek health care services. In particular, there is an urgent need to develop and evaluate ECC behavioral interventions for use in public health settings attended by high-risk children. Many authors recommend early implementation of oral health education as one means of preventing ECC. However, major issues discussed in the oral health promotion literature involve a lack of effectiveness among programs based on education alone, as well as a lack of high quality preventive interventions using evidence-based psychological and behavioral strategies. Our research team has been the first to introduce to the ECC prevention arena the self-determination theory (SDT) of motivation, internalization, and healthy functioning, proven effective in promoting positive behavioral changes in several other fields, including oral health care. The investigators have demonstrated that SDT has great promise as a motivational approach by providing evidence, based on results from our R21 (R21-DE016483) study, of the effectiveness of SDT in changing several desirable oral health behaviors for ECC prevention. Building upon the rigor of our previous experience and formative research work in the past several years, the investigators propose a Stage II NIH Model research project that will compare the efficacy of autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral videotaped messages. The investigators intend to recruit 634 pregnant mothers e
Conditions Studied
Interventions
- BEHAVIORAL Self-determination theory
Study Locations (16)
Iowa
- Anamosa WIC Clinic — Anamosa
- Belle Plaine WIC Clinic — Belle Plaine
- LCPH WIC Clinic — Cedar Rapids
- Urban WIC Clinic — Cedar Rapids
- Clinton WIC Clinic — Clinton
- Columbus Junction WIC Clinic — Columbus Junction
- Davenport WIC Clinic — Davenport
- CHC Edgerton Clinic — Davenport
- Dewitt WIC Clinic — De Witt
- Johnson County WIC — Iowa City
- Maquoketa WIC Clinic — Maquoketa
- Marion WIC Clinic — Marion
- Monticello WIC Clinic — Monticello
- Muscatine WIC Clinic — Muscatine
- Tipton WIC Clinic — Tipton
- Vinton WIC Clinic — Vinton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 634 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05756413
The ClinicalTrials.gov registry entry for NCT05756413 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 634 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 156 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Caries,Dental appearing as the primary indexed condition, and to 1 intervention — of which Self-determination theory is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05756413 reports 16 study locations spanning 1 distinct geographic area — top geographies include Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05756413 about?
NCT05756413 is a clinical study titled "Birth to Three - Cavity Free". Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the...
What is the current status of trial NCT05756413?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 634 participants. The study started on 2023-03-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05756413 study?
This clinical trial studies the following conditions: Caries,Dental. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05756413?
The interventions under investigation include: Self-determination theory (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05756413?
This trial is sponsored by University of Iowa, which has 156 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05756413 being conducted?
This trial has 16 study locations across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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