NCT04420520

Brief Summary

Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination. Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders. Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken. The results of the study will be regularly monitored by the supervisors who will have full access to these results.

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
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

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 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 3, 2020

Last Update Submit

June 4, 2020

Conditions

Keywords

MIH

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Molar Incisor Hypomineralization

    Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light.

    Through study completion, an average of 1 year

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Egyptian children in Fayoum governorate schools.

You may qualify if:

  • Acceptance for participation in the study.
  • Eruption of four first permanent molars.
  • Eruption of four permanent maxillary and mandibular incisors.
  • 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal Investigator

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

September 20, 2020

Primary Completion

April 20, 2021

Study Completion

May 20, 2021

Last Updated

June 9, 2020

Record last verified: 2020-06