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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014