Hypomineralized Second Primary MolarsNCT06753695
Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children
An observational study of Hypomineralized Second Primary Molars and Dental Hypersensitivity, run by Cairo University.
Trial summary
hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralized Second Primary Molars, Dental Hypersensitivity
- How many people
- 825 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: a group of gentian children aged form4 to 9 years old
Who may be able to join
- 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
Who cannot join
- other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Keywords
- HSPM, DH, hypo-mineralized second primary molars, hypomineralized E
What is being measured
The primary outcome is the main question the study is designed to answer.
EAPD scoring criteria and wurzberg scroring system
present/absent of the condition
Measured: 1 year
Secondary outcomes (1)
VAS scale and SCASS scale
measuring dental hypersensitivity using VAS scale and SCASS scale to reach for an association of dental hypersensitivity and HSPM
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypomineralized Second Primary MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mamdouh Ibrahim, Cairo University
- Investigators
- Aya M Ibrahim, B.D.S., Principal investigator, University of Cairo, Department of Dentistry.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753695
- Sponsor's protocol ID
- HSPM-DH-EG-2024
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hypomineralized Second Primary Molars(HSPM) and Its Association with Dental Hypersensitivity in a Group of Egyptian Children: a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT06753695
- Acronym / sponsor ID
- HSPM-DH-EG-2024
- Keywords
- HSPM, DH, hypo-mineralized second primary molars, hypomineralized E
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- a group of gentian children aged form4 to 9 years old
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EAPD scoring criteria and wurzberg scroring system
Time frame: 1 year
present/absent of the condition
1 secondary outcome
VAS scale and SCASS scale
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Hypomineralized Second Primary Molars
Not yet recruitingObservational study
Prevalence of Hypomineralized Second Primary Molars and Its Association with Molar-Incisor Hypomineralization.
Molar Incisor Hypomineralisation, Molar Incisor Hypomineralization
Not yet recruitingObservational study
Prevalence of Hypomineralized Second Primary Molars In A Group of Egyptian Children
Hypomineralization of Enamel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aya M Ibrahim, B.D.S. principal investigator
University of Cairo, Department of Dentistry.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypomineralized Second Primary Molars and Dental Hypersensitivity, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya M Ibrahim, B.D.S. (+2001003396390, aya.mamdouh@dentistry.edu.cu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EAPD scoring criteria and wurzberg scroring system (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.