Salivary Alkaline Phosphatase as a Biomarker for Dental C... | NCT05607251 | Trialant

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Salivary Alkaline Phosphatase as a Biomarker for Dental C... | NCT05607251 | Trialant

Studies
Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

NCT05607251

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 7, 2022Actual

Enrollment

21Estimated

Phase

Not provided

Conditions

Dental Caries in Children

Interventions

No intervention

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

NCT05607251

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

CUP1/11/2022

Secondary IDs

Not provided

Brief Title

Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

Official Title

Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

Acronym

Not provided

Organization

Cairo UniversityOTHER

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jan 2023Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Apr 2023Estimated

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 7, 2022Actual

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

Nov 1, 2022

Last Update Posted Date

Nov 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Salma Ahmed Abdelrahman, General Dentist, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

No

Is FDA Regulated Device

No

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aim of the study:

Assess the correlation between salivary alkaline phosphatase levels and dental caries.
Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
Assess the effect of growth of children on caries experience and severity.

Detailed Description

Not provided

Conditions Module

Conditions

Dental Caries in Children

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

No

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

21Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	There is no intervention as this is an observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary Alkaline Phosphatase levels in children with and without dental caries	Measured by spectrophotometry (unit: U/L)	2 months

Secondary Outcomes

Measure	Description	Time Frame
Caries index	Measured by DMFT and deft (unit: scores)	2 months
Caries severity	Measured by ICDAS (unit: scores)	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 6 to 8 years old.
Children with and without previous dental visits.

Exclusion Criteria:

Children with any systemic or mental illness.
Children whose parents refuse to sign the informed consent.
Children who will not cooperate on participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Children aged between 6-8 years.

Sampling Method

Probability Sample

Contacts/Locations Module

No data available

No data is available for this block.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Other

Time Perspective

Cross-Sectional

Masking Info

No data available

No data is available for this block.