- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06753695
Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children
December 23, 2024 updated by: Aya Mamdouh Ibrahim, Cairo University
Prevalence of Hypomineralized Second Primary Molars(HSPM) and Its Association with Dental Hypersensitivity in a Group of Egyptian Children: a Cross-sectional Study.
hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children
Study Overview
Status
Not yet recruiting
Detailed Description
the prevalence of the condition of hypomineralized second primary molars in a group of Egyptian children and the association of this condition to dental hypersensitivity.
Study Type
Observational
Enrollment (Estimated)
825
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya M Ibrahim, B.D.S.
- Phone Number: +2001003396390
- Email: aya.mamdouh@dentistry.edu.cu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
a group of gentian children aged form4 to 9 years old
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EAPD scoring criteria and wurzberg scroring system
Time Frame: 1 year
|
present/absent of the condition
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS scale and SCASS scale
Time Frame: 1year
|
measuring dental hypersensitivity using VAS scale and SCASS scale to reach for an association of dental hypersensitivity and HSPM
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aya M Ibrahim, B.D.S., University of Cairo, Department of Dentistry.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
December 23, 2024
First Submitted That Met QC Criteria
December 23, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSPM-DH-EG-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
IPD will be available within 12 months following publication of the primary results.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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