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

July 17, 2008
July 18, 2008
January 2007
May 2008   (final data collection date for primary outcome measure)
Sugar intake [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00719238 on ClinicalTrials.gov Archive Site
mutans streptococci levels [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study to Promote Maternal and Infant Oral Health
A Pilot Study to Promote Maternal and Infant Oral Health

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Dental Caries
  • Behavioral: Nutrition plus education
    Nutritional instruction in small groups plus education
  • Behavioral: Education only
    Educational video and pamphlets
  • Experimental: 1
    Intervention: Behavioral: Nutrition plus education
  • Active Comparator: 2
    Intervention: Behavioral: Education only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
July 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or over;
  • Pregnant
  • High S. mutans levels

Exclusion Criteria:

  • Younger than 18;
  • Other health conditions
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719238
07-093-02, CTF2007
No
Susan Reisine, University of Connecticut School of Dental Medicine
University of Connecticut Health Center
Connecticut Health Foundation
Principal Investigator: Susan Reisine, PhD University of Connecticut Health Center
University of Connecticut Health Center
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP