Prevalence of Molar Incisor Hypominerlization (MIH) Among... | NCT03498209

Studies
Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children

NCT03498209

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 15, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Molar Incisor Hypomineralization

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

May 2018

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

May 20, 2018Estimated

Primary Completion Date

Apr 20, 2019Estimated

Completion Date

May 1, 2019Estimated

First Submitted Date

Apr 7, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 13, 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

May 13, 2018

Last Update Posted Date

May 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

shahinda abdeen, Dr.shahinda abdeen pedodontist principal investigator, 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

To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.

Detailed Description

One single operator, Master degree student in the department of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. The survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on EAPD criteria

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of molar incisor hypomineralization among a group of Egyptian Children	prevalence of molar incisor hypomineralization measured by clinical examination	baseline

Secondary Outcomes

Measure	Description	Time Frame
Relationship of MIH with dental caries	Relationship of MIH with dental caries measured by caries index	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children age from eight to twelve years.
Medically free.
Singed informed consent.
Both sexes are included
Parent and children cooperation.

Exclusion Criteria:

Children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis).
Children with orthodontic bands on the first permanent molars preventing adequate clinical examination.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Data for this study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.

Participants will be selected from the outpatient's clinic of Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Cairo University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shahinda A abdeen, MCS	Contact	00201061776344		shahindaabdeen2@gmail.com
RANDA Y YOUSSEF, PHD	Contact	00201222272010		randa.youssef@yahoo.com

Overall Officials

Name	Affiliation	Role
eman S ELMASRY, PHD	Cairo University	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23230646	Background	Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.

ID	Term
D000094603	Dental Enamel Hypomineralization
D000094602	Developmental Defects of Enamel
D014071	Tooth Abnormalities
D018640	Stomatognathic System Abnormalities