A Pilot Study to Promote Maternal and Infant Oral Health
This study has been completed.
Sponsor:
University of Connecticut Health Center
Collaborator:
Connecticut Health Foundation
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00719238
First received: July 17, 2008
Last updated: July 18, 2008
Last verified: July 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 17, 2008 | ||||
| Last Updated Date | July 18, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sugar intake [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00719238 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
mutans streptococci levels [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pilot Study to Promote Maternal and Infant Oral Health | ||||
| Official Title ICMJE | A Pilot Study to Promote Maternal and Infant Oral Health | ||||
| Brief Summary | The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Dental Caries | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 121 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00719238 | ||||
| Other Study ID Numbers ICMJE | 07-093-02, CTF2007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Susan Reisine, University of Connecticut School of Dental Medicine | ||||
| Study Sponsor ICMJE | University of Connecticut Health Center | ||||
| Collaborators ICMJE | Connecticut Health Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | University of Connecticut Health Center | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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