Molar Incisor HypomineralizationMIHNCT03583671
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children From 8 to 12 Years Old in Dakahlia
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools. 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
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Dec 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
- Healthy volunteers accepted
- Child
Study population: Egyptian children aged from 8-12 years old in Dakahlia governorate schools.
Who may be able to join
- Acceptance for participation in the study.
- Children aged from 8-12 years old.
- Eruption of at four first permanent molars.
- 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.
Trial locations and contacts
No sites are listed yet.
Eslam Arafa contact
About this study
Official title: Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children Aged From Eight to Twelve Years Old in Dakahlia Governorate: A Cross Sectional Study
The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools.
Read the detailed description
- Clinical examination will be carried out in the school laboratory or an empty class, in day light, 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.
- An examination chart (Appendix 1) will be filled for each child including: date, name, age, address, gender, school, medical health and any previous dental treatment, followed by clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH and its severity based on European Academy of Pediatric Dentistry (EAPD) criteria . To diagnose Molar Incisor Hypomineralization, at least one affected first permanent molar is required. Extracted first permanent molar will be recorded as affected if another first permanent molar has a defecting MIH
- Each child affected with MIH will be given a letter outlining his dental health status, to inform the parents and indicate the need for treatment.
Examination chart
Date:
Personal information:
Name: Age: Gender:
Address:
School:
Medical history:
Dental history:
Clinical examination:
8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8
8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8
Severity according to EAPD:
Code Description Severity 0 No defect
- White or creamy demarcated opacities/mild Mild
- Yellow or brown demarcated opacities Mild
- a Enamel loss Moderate
3b Enamel and dentin loss Severe 3c Atypical large cavities extended to pulp and covering one or more tubercle Severe 4 Atypical restorations Severe 5 Extracted tooth Severe
Comments:
MIH: presence / absence Severity: Mild / Moderate /Severe
(Appendix 1)
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization , enamel defects.
- 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
measuring method:clinical examination measuring unit: binary method
Measured: 6 months
Secondary outcomes (1)
Severity of Molar Incisor Hypomineralization
measuring method: clinical examination measuring unit:Modified index (based on European Academy of Pediatric Dentistry criteria 2003, 2009)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study startNov 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mohamed Mohamed EL-Abassery, Cairo University
- Investigators
- Soad Abd EL-Moniem, Ass.prof., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583671
- Sponsor's protocol ID
- CEBD-CU-2018-06-22
- Acronym
- MIH
- Status last verified
- Jun 2018
- First submitted
- 22 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 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 Aged From Eight to Twelve Years Old in Dakahlia Governorate: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03583671
- Acronym / sponsor ID
- MIH / CEBD-CU-2018-06-22
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization , enamel defects.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jul 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.
The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools.
Detailed description
- Clinical examination will be carried out in the school laboratory or an empty class, in day light, 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.
- An examination chart (Appendix 1) will be filled for each child including: date, name, age, address, gender, school, medical health and any previous dental treatment, followed by clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH and its severity based on European Academy of Pediatric Dentistry (EAPD) criteria . To diagnose Molar Incisor Hypomineralization, at least one affected first permanent molar is required. Extracted first permanent molar will be recorded as affected if another first permanent molar has a defecting MIH
- Each child affected with MIH will be given a letter outlining his dental health status, to inform the parents and indicate the need for treatment.
Examination chart
Date:
Personal information:
Name: Age: Gender:
Address:
School:
Medical history:
Dental history:
Clinical examination:
8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8
8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8
Severity according to EAPD:
Code Description Severity 0 No defect
- White or creamy demarcated opacities/mild Mild
- Yellow or brown demarcated opacities Mild
- a Enamel loss Moderate
3b Enamel and dentin loss Severe 3c Atypical large cavities extended to pulp and covering one or more tubercle Severe 4 Atypical restorations Severe 5 Extracted tooth Severe
Comments:
MIH: presence / absence Severity: Mild / Moderate /Severe
(Appendix 1)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian children aged from 8-12 years old in Dakahlia governorate schools.
Key inclusion criteria (4 listed)
- Acceptance for participation in the study.
- Children aged from 8-12 years old.
- Eruption of at four first permanent molars.
- 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: 6 months
measuring method:clinical examination measuring unit: binary method
1 secondary outcome
Severity of Molar Incisor Hypomineralization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Eslam Arafa contact
Soad Abd EL-Moniem, Ass.prof. 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 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 11 Jul 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 Rana Mohamed EL-Abassery, Bds (01227003334, Rana.elabassiry@dentistry.cu.edu.eg), 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: 6 months). 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 11 Jul 2018.