Prevalence of Molar Incisor Hypomineralization Among a Gr... | NCT03233464

Studies
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate

NCT03233464

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 13, 2018Actual

Enrollment

374Estimated

Phase

Not provided

Conditions

Molar Incisor Hypomineralization

Interventions

Not provided

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

Feb 2018

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

May 2018Estimated

Primary Completion Date

Jun 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 28, 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

Feb 10, 2018

Last Update Posted Date

Feb 13, 2018Actual

Description Module

Brief Summary

- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .

Detailed Description

the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools.

Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom.
Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll.
A dental explorer will be further used for cleaning molar fissures.
The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities.
A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment.

prevalance of molar incisor hypomineralization is measured by presence or absence.

severity is measured by Modified index based on European Academy of Paediatric Dentistry (EAPD) criteria

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

374Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
molar incisor hypomineralization	prevalance of molar incisor hypomineralization	20 mins

Secondary Outcomes

Measure	Description	Time Frame
molar incisor hypomineralization	severity of molar incisor hypomineralization	20 mins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

schools in Giza Governorate.
Positive patient acceptance for participation in the study.
Patients who are apparently medically free from any systemic disease.

Exclusion Criteria:

Uncooperative child.
Children with appliances.

Accepts Healthy Volunteers

Yes

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

A group of Egyptian children aged 8-12 years old in Giza Governorate schools.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aya R Abd El-Ghaffar, Bachelor	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aya Refaat Abd El-Ghaffar		Giza,Egypt			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27080963	Result	Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438.
28032070	Result	Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. No abstract available.

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