Molar Incisor HypomineralizationNCT04103710
Prevalence of Molar Incisor Hypomineralization Among Children Treated With Asthmatic Drugs Early in Their Lives
An observational study of Molar Incisor Hypomineralization and Asthma in Children, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization, Asthma in Children
- How many people
- 167 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children from 8 to 12 years old with fully erupted first permanent molars and permanent incisors.
- 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.
Who cannot join
- Children with any chronic disease
- Children with unerupted or partially erupted first permanent molars.
- Children using a fixed orthodontic appliance
- Children having extensive carious lesions that might mask dental enamel defects.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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%.
- Keywords
- MIH, asthmatic drugs
- Medical subject headings
- Molar Hypomineralization
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: baseline
Secondary outcomes (1)
the severity of MIH
the severity of MIH will be recorded into three categories :Mild MIH , Moderate MIH, and Severe MIH
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start20 May 2020
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Girgis Azmy, Cairo University
- Investigators
- Marina G Azmy, BSc., Principal investigator, BSc.Faculty of Dentistry, Cairo University, 2012Marwa A Foad, MSc, Study chair, Lecturer of Pediatric Dentistry and Dental Healthsoad Abd el Moneam, PhD, Study director, Associate Professor of Pediatric Dentistry and Dental Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103710
- Sponsor's protocol ID
- MIH and asthmatic children
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2019
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25793958Wogelius 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.
PubMed 20059490Visweswar 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.
PubMed 23422632Guergolette 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.
PubMed 19466266Mastora 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.
PubMed 28255932
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04103710
- Acronym / sponsor ID
- MIH and asthmatic children
- Keywords
- MIH, asthmatic drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Children from 8 to 12 years old with fully erupted first permanent molars and permanent incisors.
- 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.
Key exclusion criteria (4 listed)
- Children with any chronic disease
- Children with unerupted or partially erupted first permanent molars.
- Children using a fixed orthodontic appliance
- Children having extensive carious lesions that might mask dental enamel defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of molar incisor hypo mineralization (MIH)
Time frame: 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:
1 secondary outcome
the severity of MIH
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 25793958Loli 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.
- Background: PubMed 20059490Wogelius 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.
- Background: PubMed 23422632Visweswar 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.
- Background: PubMed 19466266Guergolette 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.
- Background: PubMed 28255932Mastora 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.
Related trials for Molar Incisor Hypomineralization
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina G Azmy, BSc. principal investigator
BSc.Faculty of Dentistry, Cairo University, 2012
Marwa A Foad, MSc study chair
Lecturer of Pediatric Dentistry and Dental Health
soad Abd el Moneam, PhD study director
Associate Professor of Pediatric Dentistry and Dental Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization and Asthma in Children, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of molar incisor hypo mineralization (MIH) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103710, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.