Caries-associated Saliva Biomarkers Among Different Races | NCT06838182

Studies
Caries-associated Saliva Biomarkers Among Different Races

NCT06838182

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Feb 20, 2025Actual

Enrollment

22Estimated

Phase

Not provided

Conditions

Caries,Dental

Interventions

Salivary biomarkers tests

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

Feb 2025

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

Feb 25, 2025Estimated

Primary Completion Date

Mar 25, 2025Estimated

Completion Date

Apr 25, 2025Estimated

First Submitted Date

Feb 11, 2025

First Submission Date that Met QC Criteria

Feb 19, 2025

First Posted Date

Feb 20, 2025Actual

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

Feb 19, 2025

Last Update Posted Date

Feb 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

fatma ahmed mohammed el safy, Principle investigator , researcher , data enterer and writing the research, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

discover possible differences and develop effective preventative interventions by examining the relationship between salivary biomarkers and caries prevalence across different racial groups and Detect risk factors involved in caries incidence .

Detailed Description

Dental caries is a multifactorial condition that is influenced by both external and internal variables. Tooth decay progression is directly influenced by host factors, including the individual's immune competence, saliva flow rate and buffering capacity, tooth form, and bacterial makeup .

While salivary biomarkers are essential for predicting the risk of dental caries, little is known about how they relate to caries in a variety of populations. By examining the relationship between salivary biomarkers and caries prevalence across several racial groups, this study seeks to close this gap and enhance culturally appropriate preventive approaches . There have been contentious discussions over the causes of differences in oral health during the past forty years. The term "structural inequities" refers to the social, environmental, economic, and cultural determinants of health, which are frequently impacted by racial or ethnic background, gender, work status, immigrant status, and geographic location. Racialized populations have demonstrated greater rates of untreated dental decay (caries), severe periodontal disease, and total or partial edentulism . Typically, "race" refers to an individual's physical characteristics, such as skin tone or hair type, which may indicate their ancestry. White, African American, or Asian descent are some examples of classifications that are frequently used to characterize race .

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

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
caries free			Diagnostic Test: Salivary biomarkers tests
CARIES EXPERINCED			Diagnostic Test: Salivary biomarkers tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salivary biomarkers tests	Diagnostic Test	saliva samples are collected from participants	CARIES EXPERINCED caries free

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the patient has caries or not according to ELISA and colorimetric assay	Change in concentration of salivary PRP( proline rich proteins) levels (ng\ml )	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age : 19-25
We will have 2 groups according to ICDAS classification : Not severe (ICDAS score ≤3) / Severe (ICDAS score ≥3)

Exclusion Criteria:

: Those who reported daily use of alcohol or tobacco .
Those who used antibiotics or other systemic drugs within the previous three months .
Those who regularly used antiseptics

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

different races : Asian , African , Indian .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma ahmed al safy, Master degree	Contact	00201145084182		fatomalsafy@gmai.com
shereen hafez ibrahim, phd	Contact	01099296591		shereen.hafez@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26622284	Background	Abdinian M, Razavi SM, Faghihian R, Samety AA, Faghihian E. Accuracy of Digital Bitewing Radiography versus Different Views of Digital Panoramic Radiography for Detection of Proximal Caries. J Dent (Tehran). 2015 Apr;12(4):290-7.
28723991	Background	Barreto ML. Health inequalities: a global perspective. Cien Saude Colet. 2017 Jul;22(7):2097-2108. doi: 10.1590/1413-81232017227.02742017. English, Portuguese, Spanish.

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases