Prevelance of Molar Incisor Hypomineralization Among a Gr... | NCT03067064

Studies
Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children

NCT03067064

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 3, 2017Actual

Enrollment

610Estimated

Phase

Not provided

Conditions

Child Development Disorder

Interventions

no intervention

Countries

Egypt

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2017Actual

Primary Completion Date

Aug 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Feb 17, 2017

First Submission Date that Met QC Criteria

Feb 24, 2017

First Posted Date

Mar 1, 2017Actual

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 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reem Zaki Youssef, master dental student at pediatric dentistry department, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children

Detailed Description

Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

610Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	Clinical examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of Molar incisor hypomineralization	Presence of Molar incisor hypomineralization or not through clinical examination (binary)	10min

Secondary Outcomes

Measure	Description	Time Frame
Severity of Molar incisor hypomineralization	Clinical examination using modified index based on EAPD criteria	15min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university

positive patient acceptance for participation in the study
children with at least one of four permanent molars erupted or partially erupted

Exclusion Criteria:

uncooperative children
- children with appliance
- children with systemic diseases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Group of Egyptian children attending in paediatric dentistry and dental public health department in the faculty of oral and dental medicine,Cairo university

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reem Za Youssef, Bechlor	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reem Zaki Youssef		Cairo		0000	Egypt
Reem Zaki Youssef

References Module

Citations

Not provided

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders