Child Development DisorderMIHNCT03067064
Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children
An observational study of Child Development Disorder, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Development Disorder
- How many people
- 610 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Feb 2017to Oct 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Group of Egyptian children attending in paediatric dentistry and dental public health department in the faculty of oral and dental medicine,Cairo university
Who may be able to join
- Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university
- positive patient acceptance for participation in the study
- children with at least one of four permanent molars erupted or partially erupted
Who cannot join
- uncooperative children
- children with appliance
- children with systemic diseases
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prevelance of Molar Incisors Hypomineralization Among a Group of Egyptian Children
The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children
Read the detailed description
Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.
- Conditions
- Child Development Disorder
- Being tested
- no intervention
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Clinical examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Molar incisor hypomineralization
Presence of Molar incisor hypomineralization or not through clinical examination (binary)
Measured: 10min
Secondary outcomes (1)
Severity of Molar incisor hypomineralization
Clinical examination using modified index based on EAPD criteria
Measured: 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start17 Feb 2017
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development DisorderStudies 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
- 610 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Zaki Youssef, Cairo University
- Investigators
- Reem Za Youssef, Bechlor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067064
- Sponsor's protocol ID
- Ryoussef
- Acronym
- MIH
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Molar Incisors Hypomineralization Among a Group of Egyptian Children
- ClinicalTrials.gov ID
- NCT03067064
- Acronym / sponsor ID
- MIH / Ryoussef
- Conditions
- Child Development Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Mar 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.
The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children
Detailed description
Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Group of Egyptian children attending in paediatric dentistry and dental public health department in the faculty of oral and dental medicine,Cairo university
Key inclusion criteria (3 listed)
- Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university
- positive patient acceptance for participation in the study
- children with at least one of four permanent molars erupted or partially erupted
Key exclusion criteria (3 listed)
- uncooperative children
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 |
|---|---|---|
| no interventionClinical examination | Other | – |
Primary outcome
Presence of Molar incisor hypomineralization
Time frame: 10min
Presence of Molar incisor hypomineralization or not through clinical examination (binary)
1 secondary outcome
Severity of Molar incisor hypomineralization
Time frame: 15min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Yannam,s.,Amarlar,D.\&Rekha,C.,2016.prevelance of molar incisor hypomineralization in school children aged 8\_12years in chennai .journal of indian society of pedodontic and preventive dentistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Reem Za Youssef, Bechlor principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Disorder, run by Cairo University at 2 sites 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 3 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Presence of Molar incisor hypomineralization (time frame: 10min). 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 3 Mar 2017.