NCT04410172

Brief Summary

Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about the prevalence of molar incisor hypomineralization in Egyptian children.Also it will allow the early detection of molar incisor hypomineralization which will make the parents seek early treatment for it. Participants fromprimary schools in Damietta governate will be included in the study. Clinica examination will be carried out in the school lab or in embty class, in day light.

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
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 27, 2020

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of molar incisor hypomineralization.

    Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required.

    On the same day of examination

Interventions

Mirror and propeDIAGNOSTIC_TEST

Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.

Eligibility Criteria

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

A group of Egyptian children aged from 8 to 12 years old in Damietta governate.

You may qualify if:

  • positive subject acceptence for participation in the study.
  • children aged from 8 to 12 years old.
  • Eruption of at least two first permanent molars.
  • Both genders.

You may not qualify if:

  • Uncooperative child.
  • Children with prthodontic appliances.
  • Children with systemic diseases.
  • Children suffering from any other type of enamel defect as enamel hypoplasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.

    PMID: 20403298BACKGROUND
  • Allazzam SM, Alaki SM, El Meligy OA. Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014;2014:234508. doi: 10.1155/2014/234508. Epub 2014 May 8.

    PMID: 24949012BACKGROUND
  • 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.

    PMID: 23230646BACKGROUND
  • Buchgraber B, Kqiku L, Ebeleseder KA. Molar incisor hypomineralization: proportion and severity in primary public school children in Graz, Austria. Clin Oral Investig. 2018 Mar;22(2):757-762. doi: 10.1007/s00784-017-2150-y. Epub 2017 Jun 19.

    PMID: 28631087BACKGROUND
  • Da Costa-Silva CM, Ambrosano GM, Jeremias F, De Souza JF, Mialhe FL. Increase in severity of molar-incisor hypomineralization and its relationship with the colour of enamel opacity: a prospective cohort study. Int J Paediatr Dent. 2011 Sep;21(5):333-41. doi: 10.1111/j.1365-263X.2011.01128.x. Epub 2011 Apr 6.

    PMID: 21470321BACKGROUND

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

Central Study Contacts

Eman Hashem, Master degree

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
B.D.S, Faculty of Dentistry, Cairo University.

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

June 1, 2020

Record last verified: 2020-05