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

Asthma in Children Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103710
• Other study ID #: MIH and asthmatic children
• Status: Completed
• Start date: May 20, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Locations

Country	Name	City	State
Egypt	Agouza police hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Guergolette RP, Dezan CC, Frossard WT, Ferreira FB, Cerci Neto A, Fernandes KB. Prevalence of developmental defects of enamel in children and adolescents with asthma. J Bras Pneumol. 2009 Apr;35(4):295-300. doi: 10.1590/s1806-37132009000400002. English, Portuguese. — View Citation

Loli D, Costacurta M, Maturo P, Docimo R. Correlation between aerosol therapy in early childhood and Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2015 Mar;16(1):73-7. — View Citation

Mastora A, Vadiakas G, Agouropoulos A, Gartagani-Panagiotopoulou P, Gemou Engesaeth V. Developmental defects of enamel in first permanent molars associated with use of asthma drugs in preschool aged children: A retrospective case-control study. Eur Arch Paediatr Dent. 2017 Apr;18(2):105-111. doi: 10.1007/s40368-017-0280-1. Epub 2017 Mar 2. — View Citation

Visweswar VK, Amarlal D, Veerabahu R. Prevalence of developmental defects of enamel in children and adolescents with asthma: a cross-sectional study. Indian J Dent Res. 2012 Sep-Oct;23(5):697-8. doi: 10.4103/0970-9290.107432. — View Citation

Wogelius P, Haubek D, Nechifor A, Norgaard M, Tvedebrink T, Poulsen S. Association between use of asthma drugs and prevalence of demarcated opacities in permanent first molars in 6-to-8-year-old Danish children. Community Dent Oral Epidemiol. 2010 Apr;38(2):145-51. doi: 10.1111/j.1600-0528.2009.00510.x. Epub 2010 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of molar incisor hypo mineralization (MIH)	- 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	the severity of MIH	the severity of MIH will be recorded into three categories :Mild MIH , Moderate MIH, and Severe MIH	baseline