Clinical trial NCT04103710: Prevalence of Molar Incisor Hypomineralization Among Children Treated With Asthmatic Drugs Early in Their Lives
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar Incisor Hypomineralization
Asthma in Children
Keywords: MIH
asthmatic drugs
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 167
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of molar incisor hypo mineralization (MIH)
timeFrame: baseline
Secondary outcomes:
measure: the severity of MIH
timeFrame: baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Agouza police hospital
Study officials:
affiliation: BSc.Faculty of Dentistry, Cairo University, 2012
name: Marina G Azmy, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Pediatric Dentistry and Dental Health
name: Marwa A Foad, MSc
role: STUDY_CHAIR
affiliation: Associate Professor of Pediatric Dentistry and Dental Public Health
name: soad Abd el Moneam, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.