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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00334087
Other study ID # boquita HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 5, 2006
Last updated April 15, 2007
Start date June 2007
Est. completion date September 2007

Study information

Verified date April 2007
Source Hadassah Medical Organization
Contact Evelyn Mamber, DMD
Phone 00 972 2 6723771
Email mamber@bezeqint.net
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 36 Months to 48 Months
Eligibility 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)

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Behavioral:
feeding habits


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem,

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

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