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The Relation Between Pregnancy,Birth Outcome, Feeding , Oral Hygiene Habits and Early Childhood Caries Development.

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ClinicalTrials.gov Identifier: NCT00334087
Recruitment Status : Unknown
Verified April 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : June 6, 2006
Last Update Posted : April 17, 2007
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date June 5, 2006
First Posted Date June 6, 2006
Last Update Posted Date April 17, 2007
Study Start Date June 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relation Between Pregnancy,Birth Outcome, Feeding , Oral Hygiene Habits and Early Childhood Caries Development.
Official Title Assessment of Pregnancy History, Birth Outcome, Feeding and Oral Practices With Development of Early Childhood Caries in Offspring of Women Who Have Not Participated in Previous Birth Preparation Class
Brief Summary
  • 200 children between ages 36 to 48 months will be invited for a regular dental examination
  • Parameters to be investigated

    1. Pregnancy history
    2. Birth outcome
    3. Child's general health
    4. Feeding habits
    5. Oral hygiene habits
    6. Dmft caries index
    7. Congenital enamel defects
Detailed Description

Severe Early Childhood Caries is a condition whereby very young children suffer multiple caries. The value of a pre- perinatal preventive approach is currently being examined in the dental literature. At Hadassah, a Pilot Study is currently underway to test the feasibility of a comprehensive Baby Clinic designed to prevent Severe Early Childhood Caries. The pilot study in cooperation with the Woman's Health Center and with the midwives and the breastfeeding counselors of the maternity unit. Lectures are given by pediatric dentists to parents of firstborn children attending Hadassah's Birth Preparation Class, emphasis is given to the importance of breastfeeding and other feeding habits in the emotional, physical, nutritional and immunological development of the future baby. In addition the effect of these feeding habits on the dental/oral aspects, relevant for the developing dentition.

After birth the parents are invited to come with their babies around 12 months for the first dental examination and follow up according to individual risk for caries development. The current proposed study will be a control group from offspring of women who have participated previous Sessions Hadassah's Birth Preparation Class ("Historical Controls" before the Baby Clinic project)

Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Dental Caries
Intervention Behavioral: feeding habits
Study Groups/Cohorts Not Provided
Publications * Gomez SS, Weber AA. Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring. Int J Paediatr Dent. 2001 Mar;11(2):117-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†5,¬†2006)
200
Original Enrollment Same as current
Study Completion Date September 2007
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • children born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)

Exclusion Criteria:

  • children not born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
Sex/Gender
Sexes Eligible for Study: All
Ages 36 Months to 48 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00334087
Other Study ID Numbers boquita HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hadassah Medical Organization
Collaborators Not Provided
Investigators
Principal Investigator: Evelyn Mamber, DMD Hadassah Medical Organization IRB
PRS Account Hadassah Medical Organization
Verification Date April 2007