Caries-associated Saliva Biomarkers Among Different Races

February 19, 2025 updated by: fatma ahmed mohammed el safy, Cairo University

Caries-associated Saliva Biomarkers in Caries Experienced and Caries Free Population Among Different Races: Diagnostic Accuracy Study

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Estimated)

22

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

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

different races : Asian , African , Indian .

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
caries free
Diagnostic test: Salivary biomarkers tests
saliva samples are collected from participants
CARIES EXPERINCED
Diagnostic test: Salivary biomarkers tests
saliva samples are collected from participants

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 25, 2025

Primary Completion (Estimated)

March 25, 2025

Study Completion (Estimated)

April 25, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salivary biomarkers and caries

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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