NCT06727539

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
825

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 9, 2024

Last Update Submit

December 11, 2024

Conditions

Outcome Measures

Primary Outcomes (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

    Baseline

Secondary Outcomes (1)

  • Correlation of HSPM with MIH

    Baseline

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 37685598BACKGROUND
  • 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.

    PMID: 36511101BACKGROUND
  • 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.

    PMID: 37856065BACKGROUND

MeSH Terms

Conditions

Molar HypomineralizationDental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Shaimaa Sabry, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main investigator

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 11, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share