Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04103710
Other study ID # MIH and asthmatic children
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Recruiting NCT05734261 - Forced Oscillations Technique During a Metacholine Test in Children N/A
Recruiting NCT06044051 - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma N/A
Completed NCT04896502 - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers N/A
Completed NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT06003569 - Reducing Asthma Attacks in Disadvantaged School Children With Asthma N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT04388098 - Oral Health Status of Asthmatic Children
Terminated NCT03586544 - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity Phase 4
Recruiting NCT04821908 - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting NCT03277170 - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations Phase 2
Enrolling by invitation NCT06239844 - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English N/A
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Not yet recruiting NCT05974917 - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Recruiting NCT05366309 - Performance and Adherence in Children Using Spacers N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Recruiting NCT04166344 - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma N/A
Completed NCT03673618 - Soluble Corn Fiber Supplementation for Asthma Phase 2
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma