Molar Incisor HypomineralizationMIHNCT03233464
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate
An observational study of Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.
Trial summary
One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children . 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
- How many people
- 374 participants
- Where
- 1 siteEgypt
- Study dates
- May 2018to Jul 2018
- How long will I take part?
- 1 Day
- 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 8-12 years old in Giza Governorate schools.
Who may be able to join
- schools in Giza Governorate.
- Positive patient acceptance for participation in the study.
- Patients who are apparently medically free from any systemic disease.
Who cannot join
- Uncooperative child.
- Children with appliances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate: A Cross Sectional Study
- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .
Read the detailed description
the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools.
- Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom.
- Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
- Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll.
- A dental explorer will be further used for cleaning molar fissures.
- The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities.
- A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment. prevalance of molar incisor hypomineralization is measured by presence or absence. severity is measured by Modified index based on European Academy of Paediatric Dentistry (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.
molar incisor hypomineralization
prevalance of molar incisor hypomineralization
Measured: 20 mins
Secondary outcomes (1)
molar incisor hypomineralization
severity of molar incisor hypomineralization
Measured: 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startMay 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 374 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Refaat Abd El-Ghaffar, Cairo University
- Investigators
- Aya R Abd El-Ghaffar, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233464
- Sponsor's protocol ID
- ARefaat
- Acronym
- MIH
- Status last verified
- Feb 2018
- First submitted
- 25 Jul 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
Publications
Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438.
PubMed 27080963Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. No abstract available.
PubMed 28032070
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. 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 in Giza Governorate: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03233464
- Acronym / sponsor ID
- MIH / ARefaat
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Jul 2017 (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.
- One single operator will assess the prevalence of molar incisor hypomineralization and its Severity among a group of Egyptian children .
Detailed description
the study is about the prevalance of molar incisor hypomineralization and its severity among a group of Egyptian children aged 8-12 years old in Giza Governorate schools.
- Participants will be randomly selected from primary and preparatory schools in Giza governorate, seated in the school lap or an empty classroom.
- Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
- Prior to performing dental examination, index teeth including incisors and 1st permanent molars will be cleaned using a cotton roll.
- A dental explorer will be further used for cleaning molar fissures.
- The examiner carefully inspect the coronal part of the 1st permanent molars and permanent incisors for demarcated opacities.
- A specially made examination chart will be taken for the child including his name, age, address, gender, school, date, medical health and any previous dental treatment. prevalance of molar incisor hypomineralization is measured by presence or absence. severity is measured by Modified index based on European Academy of Paediatric Dentistry (EAPD) criteria
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A group of Egyptian children aged 8-12 years old in Giza Governorate schools.
Key inclusion criteria (3 listed)
- schools in Giza Governorate.
- Positive patient acceptance for participation in the study.
- Patients who are apparently medically free from any systemic disease.
Key exclusion criteria (2 listed)
- Uncooperative child.
- Children with appliances.
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
molar incisor hypomineralization
Time frame: 20 mins
prevalance of molar incisor hypomineralization
1 secondary outcome
molar incisor hypomineralization
Time frame: 20 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Results publication: PubMed 27080963Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438.
- Results publication: PubMed 28032070Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. No abstract available.
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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.
Aya R Abd El-Ghaffar, Bachelor principal investigator
Cairo University
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, 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 3 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 13 Feb 2018. 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?
Results are not available in the source record.
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?
molar incisor hypomineralization (time frame: 20 mins). 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 NCT03233464, which also lists 2 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 13 Feb 2018.