NCT03583671

Brief Summary

The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

June 22, 2018

Last Update Submit

July 10, 2018

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor Hypomineralization , enamel defects.

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Molar Incisor Hypomineralization

    measuring method:clinical examination measuring unit: binary method

    6 months

Secondary Outcomes (1)

  • Severity of Molar Incisor Hypomineralization

    6 months

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Egyptian children aged from 8-12 years old in Dakahlia governorate schools.

You may qualify if:

  • Acceptance for participation in the study.
  • Children aged from 8-12 years old.
  • Eruption of at four first permanent molars.
  • Both genders.

You may not qualify if:

  • Uncooperative children.
  • Children with orthodontic appliances.
  • Children with systemic diseases which may affect teeth development.
  • Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Soad Abd EL-Moniem, Ass.prof.

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Rana Mohamed EL-Abassery, Bds

CONTACT

01227003334Rana.elabassiry@dentistry.cu.edu.eg

Eslam Arafa

CONTACT

01228076667

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master dental student in Cairo University

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 11, 2018

Study Start

November 1, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

July 11, 2018

Record last verified: 2018-06