A Pilot Study to Promote Maternal and Infant Oral Health

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Connecticut Health Center:

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
Experimental: 1 Behavioral: Nutrition plus education
Nutritional instruction in small groups plus education
Active Comparator: 2 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 Health Center
  More Information

No publications provided

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
Study First Received: July 17, 2008
Last Updated: July 18, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014