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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04103710
Collaborator
(none)
160
1
27.4
5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    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)
    Actual Study Start Date :
    May 20, 2020
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of molar incisor hypo mineralization (MIH) [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:

    Secondary Outcome Measures

    1. the severity of MIH [baseline]

      the severity of MIH will be recorded into three categories :Mild MIH , Moderate MIH, and Severe MIH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Agouza police hospital Giza Egypt

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marina Girgis Azmy, dentist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04103710
    Other Study ID Numbers:
    • MIH and asthmatic children
    First Posted:
    Sep 25, 2019
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marina Girgis Azmy, dentist, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 10, 2022