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

Completed

• Conditions: Molar Incisor Hypomineralization; Asthma in Children

• Registration Number: NCT04103710
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Study Start: 2020-05-20
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Agouza police hospital; 🇪🇬 Giza, Egypt