Molar Incisor HypomineralizationMIHNCT03498209
Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2018to 1 May 2019
- 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
- Child
Study population: Data for this study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. Participants will be selected from the outpatient's clinic of Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Cairo University.
Who may be able to join
- Children age from eight to twelve years.
- Medically free.
- Singed informed consent.
- Both sexes are included
- Parent and children cooperation.
Who cannot join
- Children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis).
- Children with orthodontic bands on the first permanent molars preventing adequate clinical examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children: A Cross Sectional Study
To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
Read the detailed description
One single operator, Master degree student in the department of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. The survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on EAPD criteria
- Conditions
- Molar Incisor Hypomineralization
- 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 hypomineralization among a group of Egyptian Children
prevalence of molar incisor hypomineralization measured by clinical examination
Measured: baseline
Secondary outcomes (1)
Relationship of MIH with dental caries
Relationship of MIH with dental caries measured by caries index
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start20 May 2018 (estimated)
- Primary completion20 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shahinda abdeen, Cairo University
- Investigators
- eman S ELMASRY, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498209
- Sponsor's protocol ID
- prevalence of MIH
- Acronym
- MIH
- Status last verified
- May 2018
- First submitted
- 7 Apr 2018
- Last updated
- 15 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.
PubMed 23230646
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03498209
- Acronym / sponsor ID
- MIH / prevalence of MIH
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2018 (estimated)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 13 Apr 2018 (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.
To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
Detailed description
One single operator, Master degree student in the department of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. The survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on EAPD criteria
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Data for this study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. Participants will be selected from the outpatient's clinic of Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Cairo University.
Key inclusion criteria (5 listed)
- Children age from eight to twelve years.
- Medically free.
- Singed informed consent.
- Both sexes are included
- Parent and children cooperation.
Key exclusion criteria (2 listed)
- Children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis).
- Children with orthodontic bands on the first permanent molars preventing adequate clinical examination.
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 hypomineralization among a group of Egyptian Children
Time frame: baseline
prevalence of molar incisor hypomineralization measured by clinical examination
1 secondary outcome
Relationship of MIH with dental caries
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Background: PubMed 23230646Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.
- Prevalence of molar incisor hypomineralization in school children aged 8-12 years in ChennaiLink provided by the sponsor.
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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.
eman S ELMASRY, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahinda A abdeen, MCS (00201061776344, shahindaabdeen2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of molar incisor hypomineralization among a group of Egyptian Children (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 NCT03498209, which also lists 1 linked publication.
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 15 May 2018.