Effect of Malnutrition on Primary and Permanent Dentation | NCT04747028

Studies
Effect of Malnutrition on Primary and Permanent Dentation

NCT04747028

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Study Focus on the Effect of Malnutrition and Dental Problem

Interventions

Dmf score

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

Feb 2021

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

Mar 2021Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 5, 2021

First Posted Date

Feb 10, 2021Actual

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

Feb 5, 2021

Last Update Posted Date

Feb 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina mounir elkady, Lecturer at conservative department, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants

Detailed Description

The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary dentition		Children from 4 to 6 years old suffering from malnutrition	Diagnostic Test: Dmf score
Age 13 to 16		Adolecentsfrom 13 to 16 suffering from malnutrition at present time or during their childhood	Diagnostic Test: Dmf score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dmf score	Diagnostic Test	A chart to calculate the caries index	Age 13 to 16 Primary dentition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caries index	Score obtained from DMF index	1month

Secondary Outcomes

Measure	Description	Time Frame
E amel malformation	Modified DDE index	1month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

parent accept to sign the informed consent Participants not suffering from any other systematic disease

Exclusion Criteria:

non coopreative patient Suffering from systematic disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Children and adolescent diagnosed with malnutrition in the past or presnt time.patient should not suffer from any other systemic disease

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