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A Pilot Study to Promote Maternal and Infant Oral Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719238
First Posted: July 21, 2008
Last Update Posted: July 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Connecticut Health Foundation
Information provided by:
UConn Health
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study to Promote Maternal and Infant Oral Health

Resource links provided by NLM:


Further study details as provided by UConn Health:

Primary Outcome Measures:
  • Sugar intake [ Time Frame: 3 months post partum ]

Secondary Outcome Measures:
  • mutans streptococci levels [ Time Frame: 3 months post partum ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719238


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Connecticut Health Foundation
Investigators
Principal Investigator: Susan Reisine, PhD UConn Health
  More Information

Responsible Party: Susan Reisine, University of Connecticut School of Dental Medicine
ClinicalTrials.gov Identifier: NCT00719238     History of Changes
Other Study ID Numbers: 07-093-02
CTF2007
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: July 21, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases