Dental and Oral Finding in Israeli Children With Past Int... | NCT00867542

Studies
Dental and Oral Finding in Israeli Children With Past Intrauterine Growth Retardation (IUGR)

NCT00867542

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 24, 2009Estimated

Enrollment

45Estimated

Phase

Not provided

Conditions

Dental Caries

Interventions

no intervention

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Mar 22, 2009

First Submission Date that Met QC Criteria

Mar 23, 2009

First Posted Date

Mar 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2009

Last Update Posted Date

Mar 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
past IUGR		3-4 y old children with past IUGR	Other: no intervention
control		3-4 y old healthy children	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	control past IUGR

Measure	Description	Time Frame
oral status of children with past IUGR		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children who were born and diagnosed with IUGR

Exclusion Criteria:

children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

15 children aged 3-4 y old with IUGR in the past, 30 healthy children sex and age matched

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hadas Katz-Sagi, DMD	Contact	97226776168		hadaskatzsagi@gmail.com
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem	Jerusalem	91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided