Molar Incisor HypomineralizationNCT06342089
Prevalence And Severity Of Molar Incisor Hypomineralization Among A Group Of Children With Type I Diabetes Milletus.
An observational study of Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
Determine the prevalence of molar incisor hypomineralization among a group of children with type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes . Teeth will be cleaned gently using gauze and wet with saliva during examination. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Type I diabetes milletus
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to May 2025
- 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 14 years
- All sexes
- Child
Study population: * This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with types I diabetes milletus aged from( 8-14) accept to participate. * All permanent molars must be erupted as the diagnosis of molar incisor hypomineralization required at least one permanent molar involved . * The patient mustn't have any other medical conditions nor orthodontic appliance that may affect the enamel quality
Who may be able to join
- Patient aged 8 to 14 years and diagnosed with types I diabetes milletus.
- Eruption of all 4 first permanent molars.
- Acceptance to participate.
Who cannot join
- Presence of orthodontic appliance.
- Patient with any other type of enamel defect.
- Patients with any other systemic conditions rather than types I diabetes milletus that may affect tooth development.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence And Severity Of Molar Incisor Hypomineralization Among A Group Of Children With Type I Diabetes Milletus:A Cross Sectional Study.
- Determine the prevalence of molar incisor hypomineralization among a group of children with type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .
- 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 severity and treatment needs of each case with MIH will be recorded in patient's chart.
- The results of the study will be regularly monitored by the supervisors who will have full access to these results.
Read the detailed description
- This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with type I diabetes millutes.
- Details regarding participant diagnosis and treatment of type I diabetes millutes will be obtained from medical records. This includes date and the age of the child on diagnosis type I diabetes millutes, and a recent HbA1c level analysis within three months of the dental examination.
- A disposable diagnostic set (mirror, probe) were used for each child to examine the four first permanent molars , the four maxillary ,the four mandibular incisors and second primary molars to detect the presence of molar incisor hypomineralization and its severity and scores will be recorded in the chart then it will be correlated with treatment need.
- The teeth affected with molar incisor hypomineralization will be treated according to the recommendations of European academy of pediatric dentistry and the intervention will be recorded in patient's chart.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Type I diabetes milletus
- Keywords
- Molar Incisor Hypomineralization (MIH), Type I diabetes milletus(TIDM)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type I diabetes milletusOther
the exposure is type I diabetes milletus
| Study group | Role | What they receive |
|---|---|---|
| children with type I diabetes milletus | •Patient aged 8 to 14 years and diagnosed with type I diabetes milletus with erupted all 4 first permanent molars. Receives: Other: Type I diabetes milletus |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
The prevalence will be measured according to the diagnostic criteria of molar incisor Hypomineralization established by European Academy of Pediatric Dentistry.
Measuring unit: percentage
Measured: one year
Secondary outcomes (2)
Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
the severity will be measured according to:European Academy of Paediatric Dentistry (EAPD) criteria.
Measuring unit: Categorical
Measured: one year
Treatment need
The treatment need will be measured according to: treatment need index Measuring unit: Categorical l
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (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.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Samir Fahmy Auob, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342089
- Sponsor's protocol ID
- NCT06342089
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cingolani R, Stolz W, Ploog K. Electronic states and optical transitions in modulation-doped n-type GaxIn1-xAs/AlxIn1-xAs multiple quantum wells. Phys Rev B Condens Matter. 1989 Aug 15;40(5):2950-2955. doi: 10.1103/physrevb.40.2950. No abstract available.
PubMed 9992226Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.
PubMed 28721667Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022 Feb;23(1):3-21. doi: 10.1007/s40368-021-00668-5. Epub 2021 Oct 20.
PubMed 34669177Steffen R, Kramer N, Bekes K. The Wurzburg MIH concept: the MIH treatment need index (MIH TNI) : A new index to assess and plan treatment in patients with molar incisior hypomineralisation (MIH). Eur Arch Paediatr Dent. 2017 Oct;18(5):355-361. doi: 10.1007/s40368-017-0301-0. Epub 2017 Sep 14.
PubMed 28913739Mast P, Rodrigueztapia MT, Daeniker L, Krejci I. Understanding MIH: definition, epidemiology, differential diagnosis and new treatment guidelines. Eur J Paediatr Dent. 2013 Sep;14(3):204-8.
PubMed 24295005
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence And Severity Of Molar Incisor Hypomineralization Among A Group Of Children With Type I Diabetes Milletus:A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT06342089
- Acronym / sponsor ID
- NCT06342089
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization (MIH), Type I diabetes milletus(TIDM)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
- Determine the prevalence of molar incisor hypomineralization among a group of children with type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .
- 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 severity and treatment needs of each case with MIH will be recorded in patient's chart.
- The results of the study will be regularly monitored by the supervisors who will have full access to these results.
Detailed description
- This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with type I diabetes millutes.
- Details regarding participant diagnosis and treatment of type I diabetes millutes will be obtained from medical records. This includes date and the age of the child on diagnosis type I diabetes millutes, and a recent HbA1c level analysis within three months of the dental examination.
- A disposable diagnostic set (mirror, probe) were used for each child to examine the four first permanent molars , the four maxillary ,the four mandibular incisors and second primary molars to detect the presence of molar incisor hypomineralization and its severity and scores will be recorded in the chart then it will be correlated with treatment need.
- The teeth affected with molar incisor hypomineralization will be treated according to the recommendations of European academy of pediatric dentistry and the intervention will be recorded in patient's chart.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with type I diabetes milletus | – | Other: Type I diabetes milletus•Patient aged 8 to 14 years and diagnosed with type I diabetes milletus with erupted all 4 first permanent molars. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- * This cross-sectional study will be carried out by recruiting a sample of participants previously diagnosed with types I diabetes milletus aged from( 8-14) accept to participate. * All permanent molars must be erupted as the diagnosis of molar incisor hypomineralization required at least one permanent molar involved . * The patient mustn't have any other medical conditions nor orthodontic appliance that may affect the enamel quality
Key inclusion criteria (3 listed)
- Patient aged 8 to 14 years and diagnosed with types I diabetes milletus.
- Eruption of all 4 first permanent molars.
- Acceptance to participate.
Key exclusion criteria (3 listed)
- Presence of orthodontic appliance.
- Patient with any other type of enamel defect.
- Patients with any other systemic conditions rather than types I diabetes milletus that may affect tooth development.
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 |
|---|---|---|
| Type I diabetes milletusthe exposure is type I diabetes milletus | Other | children with type I diabetes milletus |
Primary outcome
prevalence of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
Time frame: one year
The prevalence will be measured according to the diagnostic criteria of molar incisor Hypomineralization established by European Academy of Pediatric Dentistry. Measuring unit: percentage
2 secondary outcomes
Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus.
Time frame: one year
Treatment need
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 9992226Cingolani R, Stolz W, Ploog K. Electronic states and optical transitions in modulation-doped n-type GaxIn1-xAs/AlxIn1-xAs multiple quantum wells. Phys Rev B Condens Matter. 1989 Aug 15;40(5):2950-2955. doi: 10.1103/physrevb.40.2950. No abstract available.
- Background: PubMed 28721667Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.
- Background: PubMed 34669177Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022 Feb;23(1):3-21. doi: 10.1007/s40368-021-00668-5. Epub 2021 Oct 20.
- Background: PubMed 28913739Steffen R, Kramer N, Bekes K. The Wurzburg MIH concept: the MIH treatment need index (MIH TNI) : A new index to assess and plan treatment in patients with molar incisior hypomineralisation (MIH). Eur Arch Paediatr Dent. 2017 Oct;18(5):355-361. doi: 10.1007/s40368-017-0301-0. Epub 2017 Sep 14.
- Background: PubMed 24295005Mast P, Rodrigueztapia MT, Daeniker L, Krejci I. Understanding MIH: definition, epidemiology, differential diagnosis and new treatment guidelines. Eur J Paediatr Dent. 2013 Sep;14(3):204-8.
- 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.
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 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 16 Jul 2024. 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 mariam samir fahmy, masters (01226493173, mariam.auob@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 among among a group of children with type I diabetes milletus. (time frame: one year). 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 NCT06342089, 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 16 Jul 2024.