A Pilot Study to Promote Maternal and Infant Oral Health - Full Text View

Sponsors and Collaborators:	University of Connecticut Health Center Connecticut Health Foundation
Information provided by:	University of Connecticut
ClinicalTrials.gov Identifier:	NCT00719238

Purpose

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.

Condition	Intervention
Dental Caries	Behavioral: Nutrition plus education Behavioral: Education only

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study to Promote Maternal and Infant Oral Health

Further study details as provided by University of Connecticut:

Primary Outcome Measures:

Sugar intake [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mutans streptococci levels [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Nutrition plus education Nutritional instruction in small groups plus education
2: Active Comparator	Behavioral: Education only Educational video and pamphlets

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18 or over;
Pregnant
High S. mutans levels

Exclusion Criteria:

Younger than 18;
Other health conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719238

Locations

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030

Sponsors and Collaborators

University of Connecticut Health Center

Connecticut Health Foundation

Investigators

Principal Investigator:

Susan Reisine, PhD

University of Connecticut

More Information

Responsible Party:	University of Connecticut School of Dental Medicine ( Susan Reisine )
Study ID Numbers:	07-093-02, CTF2007
Study First Received:	July 17, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00719238
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Tooth Diseases
Stomatognathic Diseases
Dental Caries

Additional relevant MeSH terms:

Tooth Demineralization

ClinicalTrials.gov processed this record on January 13, 2009