NCT06736535

Brief 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. 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.

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 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
16 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 12, 2024

Last Update Submit

December 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of HPC in Egyptian Children

    Baseline

  • Prevalence of HSPM in Egyptian Children

    Baseline

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children attending Outpatient clinics of Cairo University will be recruited in the study.

You may qualify if:

  • Children aged 4-9 years.
  • Cooperative patients.
  • Medically Free children.
  • Both Genders; females and males will be included.

You may not qualify if:

  • Non-Egyptian nationality.
  • Special Health Care Needs Patients.
  • Other developmental enamel defects (Non-MIH/HSPM); Amelogenesis Imperfecta, dental fluorosis and hypoplasia.
  • Other medical syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 38805129BACKGROUND
  • 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.

    PMID: 29335050BACKGROUND
  • 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.

    PMID: 25894247BACKGROUND
  • 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.

    PMID: 34544254BACKGROUND
  • 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.

    PMID: 34669177BACKGROUND

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prevalence of Hypomineralized Second Primary Molars and Its Association with Hypomineralized Primary Canines In A Group of Egyptian Children

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 16, 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