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Molar Incisor HypomineralisationNCT06727539

Prevalence of Hypomineralized Second Primary Molars and Its Association with Molar-Incisor Hypomineralization.

An observational study of Molar Incisor Hypomineralisation and Molar Incisor Hypomineralization, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim for thid study is to detect the prevalence of HSPM and the possible association between MIH and HSPM in a group of Egyptian children aged from 6-12 years. The study will also observe the possible etiological factors that might predispose hypomineralization of primary teeth. Read more about this study

Who is it for?
Ages 7 to 12 years
How many people
825 participants
Where
No sites listed yet
Study dates
1 Jan 2025to Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: The study will be done on pediatric patients with the age between 6-12 years old, attending outpatient clinic in the Department of Pediatric Dentistry and Public Health, Cairo university.

Who may be able to join

  • Both genders will be included
  • Children and adolescents with age group from 6-12 years
  • Participants who agreed to sign rhe informed consent

Who cannot join

  • Patients having enamel defects like fluorosis, amelogenesis imperfecta and dentinogenesis imperfecta
  • Special health care needs
  • Non-Egyptian children

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Shaimaa Sabry, Dr. contact

+201006495926

About this study

Official title: Prevalence of Hypomineralized Second Primary Molars in a Group of Egyptian Children and Its Association with Molar-Incisor Hypomineralization: a Cross-Sectional Study.

The aim for thid study is to detect the prevalence of HSPM and the possible association between MIH and HSPM in a group of Egyptian children aged from 6-12 years. The study will also observe the possible etiological factors that might predispose hypomineralization of primary teeth.

To our knowledge, there are no relevant studies that considered the prevalence of HSPM and its possible etiology in Egypt or its association with MIH. So, this study will address this knowledge gap. The possible relationship between HSPM and MIH is highly significant in pediatric dentistry, since the early diagnosis of HSPM as soon as second primary molars erupt makes it possible to initiate more intensive supervision and preventive measures, as these patients are otherwise prone to developing MIH in permanent teeth within a few years.

Read the detailed description

The highly mineralized tooth enamel consists of nearly 95% of hydroxyapatite crystals and are grouped into highly organized structures called enamel prisms. This structure gives the enamel an exceptional degree of mechanical resistance. Ameloblasts secrete the organic component during tooth formation, after which they polarize and are eliminated from the enamel's surface. Because it no longer contains any living supporting cells, adult enamel is incapable of regeneration.

Enamel formation by ameloblasts passes through several stages: pre-secretory, secretory, transition, maturation, and post-maturation. Depending on whether stage of the ameloblast's life cycle is affected, one can typically find either a normal volume enamel with inadequate mineralization or a fragile and quantitatively deficient enamel. When insufficient mineralization takes place, enamel defects like Molar Incisor Hypomineralization (MIH) and Hypomineralized Second Primary Molar (HPSM) can occur.

MIH is defined as hypomineralization of one to four first permanent molars presenting as well demarcated opacities, qualitative defects of enamel, atypical caries/restorations and extractions due to MIH. It's also frequently associated with the permanent incisors. As of present time, HSPM is defined as hypomineralization of one to four second deciduous molars including the presence of well demarcated opacities, post-eruptive enamel breakdown (PEB), atypical caries or restorations, and extractions due to hypomineralized second primary molars. Recently, these conditions have grabbed the attention of many clinicians across the world mainly because of the worrisome clinical picture and the challenges faced in the management of such conditions.

The etiology of HSPM still remains unclear. Despite that, some potential prenatal, perinatal and postnatal factors have been suggested. Several authors have studied the possible role of risk factors that can cause HSPM based on the medical history given by the parents using structured questionnaires. To date, not a single factor has been found to be an HSPM risk predictor. Furthermore, there is a recall bias potential because all the data obtained from the parents are history-based rather than evaluations of documented medical records.

In addition to this, multiple studies showed a positive correlation between HSPM and MIH, and HSPM being a predictor to MIH. A systematic review and a meta-analysis were done in 2018 aiming to know whether the children with HSPM are likely to have MIH or not and came up with a result that HSPM could be considered as a predictive value to MIH. It was concluded that HSPM can be considered as a specific but not a highly sensitive predictor of MIH which means that the absence of HSPM in primary molars doesn't rule out the potential development of MIH later.

In 2012, a study was done on a group sample of 1,000 Iraqi children ranging between 7-9 years old. A questionnaire-based interview about pregnancy and childhood systemic health history was completed by the mothers. Children with HSPM had greater medical issues, especially in the perinatal stage. The etiology of HSPM is still unknown because no single factor was found to be a likely cause. 94% of children with HSPM have been found to have at least one medical issue, with the likelihood of HSPM increasing with the number of medical issues; 24.5% happening prenatally, 45.3% perinatally, and 9.4% postnatally.

A prospective cohort study was done in 2014 among a 6-year-old group of children to identify possible determinants of HSPM. Data on potential factors that may have occurred during pregnancy and/or the first year of the child's life were gathered using questionnaires and manual, standardized measures (such as weight and length).

A number of pre, peri and postnatal factors have been found to be associated with HSPM.

Those factors included ethnic background, maternal alcohol consumption in pregnancy, low birth weight, and episodes of fever during the first year of the child's life.

In 2014, a study was done on the prevalence and clinical diagnosis of HSPM. Following the diagnostic criteria and the guidelines of the European Academy of Pediatric Dentistry (EAPD), it was concluded that the prevalence of HSPM varied between 4.9 and 9.0 %. HSPM was equally distributed between males and females and between upper and lower arches. It was also concluded that HSPM could be considered as a risk factor and clinical indicator for MIH and no matter how mild the expression of HSPM, it can increase the chance for developing of MIH.

Another study was done on the prevalence and pattern of HSPM among 7 to 10- year-old children in Saudi Arabia. The HSPM prevalence in that study was 5.4% at the child level and 4.8% at the tooth level. Upper right primary second molars were the most affected individual teeth in this study as compared to other primary molars. HSPM cases were found to be more in the maxillary arch as compared to the mandibular arch.

This study also observed there was a positive correlation between HSPM defect extent and increased carious lesion severity.

Concerning the possible association between HSPM and MIH, multiple studies have been done to deeply search into this issue. In 2023, a study was done in South-Western France among 856 children aged between 7-9 years in schools and randomly selected by the Academy of Bordeaux (Ministry of Education). Following the diagnostic criteria for MIH and HSPM of the European Academy of Pediatric Dentistry (EAPD), the risk of having MIH for a child who had HSPM was 52%, while the risk for a child who did not have HSPM was only 15%. The prevalence ratio was 3.4, so the risk of developing MIH was 3.4 times greater if the child had HSPM. In 2023, a cross-sectional study was done on the potential association between MIH and HSPM. The objectives were to evaluate HSPM's predictive value for the MIH and compare the prevalence of HSPM in two child groups; one having MIH and another with no MIH. It also looked into any possible relationships between HSPM severity and MIH severity in a group of children who had both conditions. The prevalence of HSPM in patients who had MIH and who didn't were 37.1% and 11.3%, respectively.

Concerning the relationship between the severity of HSPM and that of MIH in the 79 subjects who had both conditions, mild disease was the most common finding in both MIH and HSPM. 90% of cases of severe HSPM were associated with severe MIH.

A systematic review and meta-analysis were done in 2024 on the possible correlation between HSPM and MIH. Research was conducted in four databases; Embase, PubMed, Web of Science and the Cochrane Library for literature. This meta-analysis included 12 studies with 8,944 children overall. The HSPM group was more likely to experience MIH than the non-HSPM group (OR = 10.90, 95% CI = 4.59-25.89, P <0.05). Every study that was included was of a moderate to high quality.

Medical subject headings
Molar Hypomineralization, Dental Enamel Hypomineralization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of HSPM in a group of Egyptian children using EAPD scoring criteria

    Prevalence of Hypomineralized Second Primary Molars in a group of Egyptian children using EAPD (European Academy of Pediatric Dentistry) scoring criteria

    Measured: Baseline

Secondary outcomes (1)
  1. Correlation of HSPM with MIH

    Correlation of Hypomineralized Second Primary Molars with Molar Incisor Hypomineralization using binary outcome (Present/Absent)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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-control
Time perspective
Retrospective
Enrolment
825 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727539
Sponsor's protocol ID
HSPM in Egyptian children
Status last verified
Dec 2024
First submitted
9 Dec 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marcianes M, Garcia-Camba P, Albaladejo A, Varela Morales M. Predictive Value of Hypomineralization of Second Primary Molars for Molar Incisor Hypomineralization and Other Relationships between Both Developmental Defects of Dental Enamel. J Clin Med. 2023 Aug 25;12(17):5533. doi: 10.3390/jcm12175533.

    PubMed 37685598
  • Estivals J, Fahd C, Baillet J, Rouas P, Manton DJ, Garot E. The prevalence and characteristics of and the association between MIH and HSPM in South-Western France. Int J Paediatr Dent. 2023 May;33(3):298-304. doi: 10.1111/ipd.13040. Epub 2022 Dec 27.

    PubMed 36511101
  • Bekes K, Steffen R, Kramer N. Update of the molar incisor hypomineralization: Wurzburg concept. Eur Arch Paediatr Dent. 2023 Dec;24(6):807-813. doi: 10.1007/s40368-023-00848-5. Epub 2023 Oct 19.

    PubMed 37856065

Questions about this trial

What is this clinical trial studying?

An observational study of Molar Incisor Hypomineralisation and 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: opening soon, as of the sponsor's last update on 16 Dec 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nada ElSaeid (+201275907807, nada.elsaeid@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 HSPM in a group of Egyptian children using EAPD scoring criteria (time frame: Baseline). 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 NCT06727539, which also lists 3 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 Dec 2024.

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