Oral Health Status and Diet History Analysis Among Orphan... | NCT04167826

Studies
Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate.

NCT04167826

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 19, 2019Actual

Enrollment

115Estimated

Phase

Not provided

Conditions

Gingival Disease Due to Bacteria

Interventions

Not provided

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

Nov 2019

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

Nov 2019Estimated

Primary Completion Date

Feb 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Nov 14, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 19, 2019Actual

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

Nov 18, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate.

Detailed Description

The study's investigators will record all data related to oral health status of orphan children from 10-14 years and their dietary habits to describe usual food intake and its variation over a long period of time . the OHI-S will also recorded which has 2 components the Debris index and Calculus index .

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

115Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oral health status	Debris index	3 months
oral health status	Calculus index	3 months
Diet history analysis	Diet history chart	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egyptian children aged from 10-14 years
Cooperative children

Exclusion Criteria:

Children with systemic disease , genetic disorders , or any disabilities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

This study will done for Orphan children in Resalaa charity organization in Cairo governorate in Egypt.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdulrahman mohamed salah, master	Contact	01061879577		Dr.arms7@gmail.com

Overall Officials

Name	Affiliation	Role
Sherine Ezz eldeen, professor	Cairo University	Study Director

Locations

Not provided

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