Back to resultsA Pilot Study to Promote Maternal and Infant Oral Health
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition plus education
Education only
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Age 18 or over;
- Pregnant
- High S. mutans levels
Exclusion Criteria:
- Younger than 18;
- Other health conditions
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Sugar intake
Secondary Outcome Measures
mutans streptococci levels
Full Information
NCT ID
NCT00719238
First Posted
July 17, 2008
Last Updated
July 18, 2008
Sponsor
UConn Health
Collaborators
Connecticut Health Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00719238
Brief Title
A Pilot Study to Promote Maternal and Infant Oral Health
Official Title
A Pilot Study to Promote Maternal and Infant Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UConn Health
Collaborators
Connecticut Health Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Nutrition plus education
Intervention Description
Nutritional instruction in small groups plus education
Intervention Type
Behavioral
Intervention Name(s)
Education only
Intervention Description
Educational video and pamphlets
Primary Outcome Measure Information:
Title
Sugar intake
Time Frame
3 months post partum
Secondary Outcome Measure Information:
Title
mutans streptococci levels
Time Frame
3 months post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or over;
Pregnant
High S. mutans levels
Exclusion Criteria:
Younger than 18;
Other health conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Reisine, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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A Pilot Study to Promote Maternal and Infant Oral Health
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