Molar Incisor HypomineralizationNCT04420520
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination. Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2020to 20 May 2021
- 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 6 to 14 years
- All sexes
- Child
Study population: Egyptian children in Fayoum governorate schools.
Who may be able to join
- Acceptance for participation in the study.
- Eruption of four first permanent molars.
- Eruption of four permanent maxillary and mandibular incisors.
- Both genders.
Who cannot join
- Uncooperative children.
- Children with orthodontic appliances.
- Children with systemic diseases which may affect teeth development.
- Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.
About this study
Official title: Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools: A Cross Sectional Study
Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination.
Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders.
Read more
Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
The results of the study will be regularly monitored by the supervisors who will have full access to these results.
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- MIH
- 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
Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 Sep 2020 (estimated)
- Primary completion20 Apr 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Snoussy Abo-alsaod, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420520
- Sponsor's protocol ID
- CEBD-CU-2020-05-13
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 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 in Fayoum Governorate Schools: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04420520
- Acronym / sponsor ID
- CEBD-CU-2020-05-13
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- MIH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (estimated)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 9 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.
Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination.
Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders.
Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
The results of the study will be regularly monitored by the supervisors who will have full access to these results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Egyptian children in Fayoum governorate schools.
Key inclusion criteria (4 listed)
- Acceptance for participation in the study.
- Eruption of four first permanent molars.
- Eruption of four permanent maxillary and mandibular incisors.
- Both genders.
Key exclusion criteria (4 listed)
- Uncooperative children.
- Children with orthodontic appliances.
- Children with systemic diseases which may affect teeth development.
- Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.
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
Time frame: Through study completion, an average of 1 year
Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 9 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?
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 Hypomineralization (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.