Prevalence of Molar Incisor Hypomineralization Among Children Treated With Asthmatic Drugs Early in Their Lives

September 4, 2023 updated by: Marina Girgis Azmy, Cairo University

Prevalence of Molar Incisor Hypo Mineralization Among Children Who Have Been Treated With Asthmatic Drugs During Their First Three Years of Life(A Cross- Sectional Study)

The aim of this study is to assess the prevalence of molar incisor hypo mineralization among children who have been treated with asthmatic drugs during the first three years of life.

Study Overview

Status

Completed

Conditions

Detailed Description

The term Molar incisor hypo mineralization (MIH) was first introduced in 2001 as a developmental disorder of enamel characterized by hypo mineralization -of systemic origin - affecting the enamel of first permanent molars (PFM) ,frequently associated with affected permanent incisors.

The prevalence of MIH varies widely, ranging from 2.4 % to 40.2% in different populations. This wide variation may be due to differences in diagnostic criteria and methodologies used by the authors. Concerning the etiology of MIH it is mostly related to pre natal, perinatal, and post natal illness.

Asthma and asthmatic drugs have been proposed to be one of the etiological factors of MIH,Internationally, the mean prevalence of pediatric asthma is 10%.

Study Type

Observational

Enrollment (Actual)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Agouza police hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children aged from 8 to 12 years old with fully erupted first permanent molar and permanent incisors, who have been treated with any type of asthmatic drugs during their first three years of life.

Description

Inclusion Criteria:

  1. Children from 8 to 12 years old with fully erupted first permanent molars and permanent incisors.
  2. Children who were patients of the Pediatric Pulmonary Clinic and had used asthma drugs (oral and inhaled bronchodilators or corticosteroids) during their first three years of life.

Exclusion Criteria:

  1. Children with any chronic disease
  2. Children with unerupted or partially erupted first permanent molars.
  3. Children using a fixed orthodontic appliance
  4. Children having extensive carious lesions that might mask dental enamel defects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of molar incisor hypo mineralization (MIH)
Time Frame: baseline

- Clinical examination will be carried out by the principle investigator using mirror and probe to examine all surfaces of each first permanent molar &permanent incisors following the diagnostic criteria of MIH set by the European Academy of Pediatric Dentistry (EAPD)as following :Demarcated opacities:

Enamel disintegration:

Atypical restorations:

Extracted teeth:

Tooth sensitivity:
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the severity of MIH
Time Frame: baseline
the severity of MIH will be recorded into three categories :Mild MIH , Moderate MIH, and Severe MIH
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Marina G Azmy, BSc., BSc.Faculty of Dentistry, Cairo University, 2012
  • Study Chair: Marwa A Foad, MSc, Lecturer of Pediatric Dentistry and Dental Health
  • Study Director: soad Abd el Moneam, PhD, Associate Professor of Pediatric Dentistry and Dental Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIH and asthmatic children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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