NCT06753695

Brief Summary

hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children

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 Mar 2025

Shorter than P25 for all trials

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 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

December 23, 2024

Last Update Submit

December 23, 2024

Conditions

Keywords

HSPMDHhypo-mineralized second primary molarshypomineralized E

Outcome Measures

Primary Outcomes (1)

  • EAPD scoring criteria and wurzberg scroring system

    present/absent of the condition

    1 year

Secondary Outcomes (1)

  • VAS scale and SCASS scale

    1year

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

a group of gentian children aged form4 to 9 years old

You may qualify if:

  • Egyptian children
  • cooperative patients both genders and included 4-9 years old children at least one HSPM affected molar and one non affected molar absence of syndromes or craniofacial anomalies

You may not qualify if:

  • other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Aya M Ibrahim, B.D.S.

    University of Cairo, Department of Dentistry.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist and Principal Investigato

Study Record Dates

First Submitted

December 23, 2024

First Posted

December 31, 2024

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
IPD will be available within 12 months following publication of the primary results.