Molar Incisor HypomineralizationNCT04410172
Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta
An observational study of Molar Incisor Hypomineralization, run by Eman Zakaria Ali Hashem.
Trial summary
Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Mirror and prope
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2021
- 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
- Healthy volunteers accepted
- Child
Study population: A group of Egyptian children aged from 8 to 12 years old in Damietta governate.
Who may be able to join
- positive subject acceptence for participation in the study.
- children aged from 8 to 12 years old.
- Eruption of at least two first permanent molars.
- Both genders.
Who cannot join
- Uncooperative child.
- Children with prthodontic appliances.
- Children with systemic diseases.
- Children suffering from any other type of enamel defect as enamel hypoplasia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Molar Incisor Hypomineralization Among a Group Of Egyptian Children Aged From 8 to 12 Years Old in Damietta
Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about the prevalence of molar incisor hypomineralization in Egyptian children.Also it will allow the early detection of molar incisor hypomineralization which will make the parents seek early treatment for it. Participants fromprimary schools in Damietta governate will be included in the study. Clinica examination will be carried out in the school lab or in embty class, in day light.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Mirror and prope
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror and propeDiagnostic test
Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of molar incisor hypomineralization.
Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required.
Measured: On the same day of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
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.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Zakaria Ali Hashem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Zakaria Ali Hashem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410172
- Sponsor's protocol ID
- EMAN91
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.
PubMed 20403298Allazzam SM, Alaki SM, El Meligy OA. Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014;2014:234508. doi: 10.1155/2014/234508. Epub 2014 May 8.
PubMed 24949012Biondi 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 23230646Buchgraber B, Kqiku L, Ebeleseder KA. Molar incisor hypomineralization: proportion and severity in primary public school children in Graz, Austria. Clin Oral Investig. 2018 Mar;22(2):757-762. doi: 10.1007/s00784-017-2150-y. Epub 2017 Jun 19.
PubMed 28631087Da Costa-Silva CM, Ambrosano GM, Jeremias F, De Souza JF, Mialhe FL. Increase in severity of molar-incisor hypomineralization and its relationship with the colour of enamel opacity: a prospective cohort study. Int J Paediatr Dent. 2011 Sep;21(5):333-41. doi: 10.1111/j.1365-263X.2011.01128.x. Epub 2011 Apr 6.
PubMed 21470321
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Molar Incisor Hypomineralization Among a Group Of Egyptian Children Aged From 8 to 12 Years Old in Damietta
- ClinicalTrials.gov ID
- NCT04410172
- Acronym / sponsor ID
- EMAN91
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Eman Zakaria Ali HashemUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 1 Jun 2020 (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.
Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about the prevalence of molar incisor hypomineralization in Egyptian children.Also it will allow the early detection of molar incisor hypomineralization which will make the parents seek early treatment for it. Participants fromprimary schools in Damietta governate will be included in the study. Clinica examination will be carried out in the school lab or in embty class, in day light.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A group of Egyptian children aged from 8 to 12 years old in Damietta governate.
Key inclusion criteria (4 listed)
- positive subject acceptence for participation in the study.
- children aged from 8 to 12 years old.
- Eruption of at least two first permanent molars.
- Both genders.
Key exclusion criteria (4 listed)
- Uncooperative child.
- Children with prthodontic appliances.
- Children with systemic diseases.
- Children suffering from any other type of enamel defect as enamel hypoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror and propeMirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation. | Diagnostic test | – |
Primary outcome
Prevalence of molar incisor hypomineralization.
Time frame: On the same day of examination
Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 20403298Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.
- Background: PubMed 24949012Allazzam SM, Alaki SM, El Meligy OA. Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014;2014:234508. doi: 10.1155/2014/234508. Epub 2014 May 8.
- 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.
- Background: PubMed 28631087Buchgraber B, Kqiku L, Ebeleseder KA. Molar incisor hypomineralization: proportion and severity in primary public school children in Graz, Austria. Clin Oral Investig. 2018 Mar;22(2):757-762. doi: 10.1007/s00784-017-2150-y. Epub 2017 Jun 19.
- Background: PubMed 21470321Da Costa-Silva CM, Ambrosano GM, Jeremias F, De Souza JF, Mialhe FL. Increase in severity of molar-incisor hypomineralization and its relationship with the colour of enamel opacity: a prospective cohort study. Int J Paediatr Dent. 2011 Sep;21(5):333-41. doi: 10.1111/j.1365-263X.2011.01128.x. Epub 2011 Apr 6.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization, run by Eman Zakaria Ali Hashem.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Jun 2020. 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 Eman Hashem, Master degree ((02) 01092990480, eman91hashem@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. (time frame: On the same day of examination). 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 NCT04410172, 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 1 Jun 2020.