Hypomineralization of EnamelNCT06736535
Prevalence of Hypomineralized Second Primary Molars In A Group of Egyptian Children
An observational study of Hypomineralization of Enamel, run by Cairo University.
Trial summary
Aim of the study: This study aims to detect the prevalence of hypomineralized second primary molars and its association with hypomineralized primary canines in a group of Egyptian children. Furthermore, it also addresses the possible etiological factors that might predispose hypomineralization of deciduous teeth. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Hypomineralization of Enamel
- How many people
- 825 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 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 4 to 9 years
- All sexes
- Child
Study population: Children attending Outpatient clinics of Cairo University will be recruited in the study.
Who may be able to join
- Children aged 4-9 years.
- Cooperative patients.
- Medically Free children.
- Both Genders; females and males will be included.
Who cannot join
- Non-Egyptian nationality.
- Special Health Care Needs Patients.
- Other developmental enamel defects (Non-MIH/HSPM); Amelogenesis Imperfecta, dental fluorosis and hypoplasia.
- Other medical syndromes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Hypomineralized Second Primary Molars and Its Association With Hypomineralized Primary Canines In A Group of Egyptian Children: A Cross-Sectional Study.
Aim of the study: This study aims to detect the prevalence of hypomineralized second primary molars and its association with hypomineralized primary canines in a group of Egyptian children. Furthermore, it also addresses the possible etiological factors that might predispose hypomineralization of deciduous teeth.
Rationale:
This study tends to fill the knowledge gap about the prevalence of hypomineralized second primary molars as well as its association with hypomineralized primary canines in a group of Egyptian children. In addition to identifying the possible predisposing etiological factors.
Read the detailed description
Developmental defects of enamel are common among deciduous and permanent dentition. One of these defects is termed molar incisor hypomineralization which refers to a qualitative defect in the enamel due to disruption in the process of calcification and maturation of ameloblasts. The most remarkable clinical appearance of the lesion is the weak quality of enamel which leads to teeth being susceptible to decay .
In 2011 a standardized scoring criteria was introduced by the European Academy of Pediatric Dentistry for proper diagnosis of MIH. Moreover, to distinguish MIH from other developmental enamel defects. Due to the poor quality of enamel, patients with MIH are prone to several challenges like hypersensitivity, dental pain and post eruptive enamel breakdown which creates drawbacks for the dentist to properly manage the case
A study conducted in 2013 referred to MIH occurring in primary dentition and was primarily termed as deciduous molar hypomineralization (DMH). Teeth was recorded using EAPD diagnostic criteria and the prevalence of DMH was 4% in teeth examined in a sample of 6,487 participating children. In addition, they found that the occurrence of MIH in children affected with HSPM was of higher results. Furthermore, children with more than one affected molar represented severe form of HSPM.
Another study conducted on Iraqi children to detect the prevalence and severity of HSPM on a sample of 809 children aging 7-9 years showed 6.6%. By using the EAPD scoring criteria and International Caries Detection and Assessment System the study revealed that more severe form of caries was proportional with the amount of demarcated lesion, moreover 39.6% of the cases examined showed correlation between HSPM and MIH.
The American Academy of Pediatric Dentistry in 2017 published a study that detected the prevalence of HSPM and HPC in a group of 1963 schoolchildren, the results were 6.48% and 2.22% respectively by adapting the EAPD scoring criteria and the Caries Assessment Spectrum and Treatment. Considering the severity, 70% of the affected cases reported mild to moderate hypomineralization. Furthermore, the study reported children diagnosed with HSPM or HPC are six times more likely to develop MIH.
Another study was implemented in 2021 to detect prevalence of HSPM/HPC and to mark out the lesion characteristics, location and severity. Guided by the EAPD scoring criteria the results are as follows, in a sample of 153 patients HSPM showed 18.95% and HPC showed 11.11%. The lesions were mostly detected on the buccal and occlusal surfaces. This study measured the severity in 153 samples to report majority of lesions exhibiting mild degree severity.
A study that was conducted in North India to detect the prevalence of HSPM showed 7.9% in a sample of 300 patients. In addition to determining the possible etiological factors behind the occurrence of HSPM. The etiology remains uncertain, however based on the data collected from medical reports and from the parents, the study concluded that prenatal and post-natal factors showed higher prevalence of HSPM than perinatal factors.
- Conditions
- Hypomineralization of Enamel
- Medical subject headings
- Dental Enamel Hypomineralization
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPC in Egyptian Children
Measured: Baseline
Prevalence of HSPM in Egyptian Children
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (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 Hypomineralization of EnamelStudies 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
- Cross-sectional
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Khalid Noaman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736535
- Sponsor's protocol ID
- HPC in Egyptian Children
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
PubMed 38805129da Silva Figueiredo Se MJ, Ribeiro APD, Dos Santos-Pinto LAM, de Cassia Loiola Cordeiro R, Cabral RN, Leal SC. Are Hypomineralized Primary Molars and Canines Associated with Molar-Incisor Hypomineralization? Pediatr Dent. 2017 Nov 1;39(7):445-449.
PubMed 29335050Elfrink ME, Ghanim A, Manton DJ, Weerheijm KL. Standardised studies on Molar Incisor Hypomineralisation (MIH) and Hypomineralised Second Primary Molars (HSPM): a need. Eur Arch Paediatr Dent. 2015 Jun;16(3):247-55. doi: 10.1007/s40368-015-0179-7. Epub 2015 Apr 18.
PubMed 25894247Borrego-Marti N, Peris-Corominas R, Maura-Solivellas I, Ferres-Padro E, Ferres-Amat E. Hypomineralisation of second primary molars and primary canines: Prevalence and description of lesions in a population of 153 patients visited at a hospital paediatric dentistry service. Eur J Paediatr Dent. 2021 Sep;22(3):237-242. doi: 10.23804/ejpd.2021.22.03.11.
PubMed 34544254Lygidakis 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 34669177
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypomineralized Second Primary Molars and Its Association With Hypomineralized Primary Canines In A Group of Egyptian Children: A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT06736535
- Acronym / sponsor ID
- HPC in Egyptian Children
- Conditions
- Hypomineralization of Enamel
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 16 Dec 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.
Aim of the study: This study aims to detect the prevalence of hypomineralized second primary molars and its association with hypomineralized primary canines in a group of Egyptian children. Furthermore, it also addresses the possible etiological factors that might predispose hypomineralization of deciduous teeth.
Rationale:
This study tends to fill the knowledge gap about the prevalence of hypomineralized second primary molars as well as its association with hypomineralized primary canines in a group of Egyptian children. In addition to identifying the possible predisposing etiological factors.
Detailed description
Developmental defects of enamel are common among deciduous and permanent dentition. One of these defects is termed molar incisor hypomineralization which refers to a qualitative defect in the enamel due to disruption in the process of calcification and maturation of ameloblasts. The most remarkable clinical appearance of the lesion is the weak quality of enamel which leads to teeth being susceptible to decay .
In 2011 a standardized scoring criteria was introduced by the European Academy of Pediatric Dentistry for proper diagnosis of MIH. Moreover, to distinguish MIH from other developmental enamel defects. Due to the poor quality of enamel, patients with MIH are prone to several challenges like hypersensitivity, dental pain and post eruptive enamel breakdown which creates drawbacks for the dentist to properly manage the case
A study conducted in 2013 referred to MIH occurring in primary dentition and was primarily termed as deciduous molar hypomineralization (DMH). Teeth was recorded using EAPD diagnostic criteria and the prevalence of DMH was 4% in teeth examined in a sample of 6,487 participating children. In addition, they found that the occurrence of MIH in children affected with HSPM was of higher results. Furthermore, children with more than one affected molar represented severe form of HSPM.
Another study conducted on Iraqi children to detect the prevalence and severity of HSPM on a sample of 809 children aging 7-9 years showed 6.6%. By using the EAPD scoring criteria and International Caries Detection and Assessment System the study revealed that more severe form of caries was proportional with the amount of demarcated lesion, moreover 39.6% of the cases examined showed correlation between HSPM and MIH.
The American Academy of Pediatric Dentistry in 2017 published a study that detected the prevalence of HSPM and HPC in a group of 1963 schoolchildren, the results were 6.48% and 2.22% respectively by adapting the EAPD scoring criteria and the Caries Assessment Spectrum and Treatment. Considering the severity, 70% of the affected cases reported mild to moderate hypomineralization. Furthermore, the study reported children diagnosed with HSPM or HPC are six times more likely to develop MIH.
Another study was implemented in 2021 to detect prevalence of HSPM/HPC and to mark out the lesion characteristics, location and severity. Guided by the EAPD scoring criteria the results are as follows, in a sample of 153 patients HSPM showed 18.95% and HPC showed 11.11%. The lesions were mostly detected on the buccal and occlusal surfaces. This study measured the severity in 153 samples to report majority of lesions exhibiting mild degree severity.
A study that was conducted in North India to detect the prevalence of HSPM showed 7.9% in a sample of 300 patients. In addition to determining the possible etiological factors behind the occurrence of HSPM. The etiology remains uncertain, however based on the data collected from medical reports and from the parents, the study concluded that prenatal and post-natal factors showed higher prevalence of HSPM than perinatal factors.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Age groups
- Child
- Study population
- Children attending Outpatient clinics of Cairo University will be recruited in the study.
Key inclusion criteria (4 listed)
- Children aged 4-9 years.
- Cooperative patients.
- Medically Free children.
- Both Genders; females and males will be included.
Key exclusion criteria (4 listed)
- Non-Egyptian nationality.
- Special Health Care Needs Patients.
- Other developmental enamel defects (Non-MIH/HSPM); Amelogenesis Imperfecta, dental fluorosis and hypoplasia.
- Other medical syndromes.
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 HPC in Egyptian Children
Time frame: Baseline
Prevalence of HSPM in Egyptian Children
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 38805129Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Background: PubMed 29335050da Silva Figueiredo Se MJ, Ribeiro APD, Dos Santos-Pinto LAM, de Cassia Loiola Cordeiro R, Cabral RN, Leal SC. Are Hypomineralized Primary Molars and Canines Associated with Molar-Incisor Hypomineralization? Pediatr Dent. 2017 Nov 1;39(7):445-449.
- Background: PubMed 25894247Elfrink ME, Ghanim A, Manton DJ, Weerheijm KL. Standardised studies on Molar Incisor Hypomineralisation (MIH) and Hypomineralised Second Primary Molars (HSPM): a need. Eur Arch Paediatr Dent. 2015 Jun;16(3):247-55. doi: 10.1007/s40368-015-0179-7. Epub 2015 Apr 18.
- Background: PubMed 34544254Borrego-Marti N, Peris-Corominas R, Maura-Solivellas I, Ferres-Padro E, Ferres-Amat E. Hypomineralisation of second primary molars and primary canines: Prevalence and description of lesions in a population of 153 patients visited at a hospital paediatric dentistry service. Eur J Paediatr Dent. 2021 Sep;22(3):237-242. doi: 10.23804/ejpd.2021.22.03.11.
- 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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypomineralization of Enamel, 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: 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 Farida Khalid Noaman (01060511700, farida.noaman@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 HPC in Egyptian Children (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06736535, 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 Dec 2024.