- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736535
Prevalence of Hypomineralized Second Primary Molars In A Group of Egyptian Children
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Farida Khalid Noaman
- Phone Number: 01060511700
- Email: farida.noaman@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 4-9 years.
- Cooperative patients.
- Medically Free children.
- Both Genders; females and males will be included.
Exclusion Criteria:
- Non-Egyptian nationality.
- Special Health Care Needs Patients.
- Other developmental enamel defects (Non-MIH/HSPM); Amelogenesis Imperfecta, dental fluorosis and hypoplasia.
- Other medical syndromes.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of HPC in Egyptian Children
Time Frame: Baseline
|
Baseline
|
|
Prevalence of HSPM in Egyptian Children
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Elfrink 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.
- Lygidakis 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.
- 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.
- da 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.
- Borrego-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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HPC in Egyptian Children
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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