the Effect of Prenatal Vitamins on the Tooth Structure | NCT03598972

Studies
the Effect of Prenatal Vitamins on the Tooth Structure

NCT03598972

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 1, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Dental Caries

Interventions

intervention

Countries

Not provided

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 2020

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 15, 2021Estimated

Primary Completion Date

Jul 15, 2021Estimated

Completion Date

Jul 15, 2021Estimated

First Submitted Date

Jul 16, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 26, 2018Actual

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 30, 2020

Last Update Posted Date

Apr 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not

Detailed Description

teeth lost due to normal shedding will be collected,it will be classified into mother that take pregnancy vitamins and mother that doesn't take pregnancy vitamins, the female will be from the same population and from the same city to make sure that the environmental condition are almost the same .teeth will be subjected to elementary analysis to determine the different ratio of different component and if there is any change between the two group

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		teeth of children of non vitamin taking mother	Other: intervention
intervention		children teeth of vitamin taking mother	Other: intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intervention	Other	elementary analysis	control intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the different teeth minerals and component	analysis of exofilated teeth mineral ratio	3months

Secondary Outcomes

Measure	Description	Time Frame
caries index of chlidren	dmf index for every patient to count the total missed and decayed teeth	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria teeth lost due to normal shedding sound teeth with non hereditary conditions normal children mother that don not suffer from chronic illness ex: diabetes

Exclusion Criteria:

teeth extracted due to caries or trauma teeth with hereditary anomalies ex: hypoplasia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

healthy children within the normal period of teeth shedding

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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