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NCT00719238 Clinical Trial

A Pilot Study to Promote Maternal and Infant Oral Health

Dental Caries Clinical Trial

Official title:
A Pilot Study to Promote Maternal and Infant Oral Health

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00719238
Other study ID # 07-093-02
Secondary ID CTF2007
Status Completed
Phase N/A
First received July 17, 2008
Last updated July 18, 2008
Start date January 2007
Est. completion date July 2008

Study information
Verified date July 2008
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date July 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or over;

- Pregnant

- High S. mutans levels

Exclusion Criteria:

- Younger than 18;

- Other health conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Nutrition plus education
Nutritional instruction in small groups plus education
• Education only
Educational video and pamphlets

Locations
Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)
Lead Sponsor Collaborator
University of Connecticut Health Center Connecticut Health Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sugar intake 3 months post partum No
Secondary mutans streptococci levels 3 months post partum No
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