Prevalence of Hypomineralized Second Primary Molars and T... | NCT06753695

Studies
Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children

NCT06753695

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Dec 31, 2024Actual

Enrollment

825Estimated

Phase

Not provided

Conditions

Hypomineralized Second Primary Molars
Dental Hypersensitivity

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Dec 23, 2024

First Submission Date that Met QC Criteria

Dec 23, 2024

First Posted Date

Dec 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2024

Last Update Posted Date

Dec 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

825Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EAPD scoring criteria and wurzberg scroring system	present/absent of the condition	1 year

Secondary Outcomes

Measure	Description	Time Frame
VAS scale and SCASS scale	measuring dental hypersensitivity using VAS scale and SCASS scale to reach for an association of dental hypersensitivity and HSPM	1year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

a group of gentian children aged form4 to 9 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aya M Ibrahim, B.D.S.	Contact	+2001003396390		aya.mamdouh@dentistry.edu.cu.eg

Overall Officials

Name	Affiliation	Role
Aya M Ibrahim, B.D.S.	University of Cairo, Department of Dentistry.	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Informed Consent Form (ICF)
Analytic Code

Time Frame

IPD will be available within 12 months following publication of the primary results.

Access Criteria

Not provided

URL

Not provided