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Caries,DentalNCT06838182

Caries-associated Saliva Biomarkers Among Different Races

An observational study of Caries,Dental, run by Cairo University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Caries,Dental
What is being tested?
Salivary biomarkers tests
How many people
22 participants
Where
No sites listed yet
Study dates
25 Feb 2025to 25 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 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: different races : Asian , African , Indian .

Who may be able to join

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

Who cannot join

  • : 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Fatma ahmed al safy, Master degree contact

00201145084182

fatomalsafy@gmai.com

shereen hafez ibrahim, phd contact

01099296591

shereen.hafez@dentistry.cu.edu.eg

About this study

Official title: 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 .

Read the 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 .

Conditions
Caries,Dental
Being tested
Salivary biomarkers tests
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salivary biomarkers testsDiagnostic test

    saliva samples are collected from participants

Study groups in NCT06838182
Study groupRoleWhat they receive
caries freeNot described
Receives: Diagnostic Test: Salivary biomarkers tests
CARIES EXPERINCEDNot described
Receives: Diagnostic Test: Salivary biomarkers tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the patient has caries or not according to ELISA and colorimetric assay

    Change in concentration of salivary PRP( proline rich proteins) levels (ng\ml )

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start25 Feb 2025 (estimated)
  3. Primary completion25 Mar 2025 (estimated)
  4. Study completion25 Apr 2025 (estimated)

Resources

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
Prospective
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838182
Sponsor's protocol ID
Salivary biomarkers and caries
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
20 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26622284

  • 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.

    PubMed 28723991

  • Beckfield J, Olafsdottir S. Health Inequalities in Global Context. Am Behav Sci. 2013;57(8):1014-1039. doi: 10.1177/0002764213487343. Epub 2013 Jun 26.

    PubMed 29104292

  • Cash-Gibson L, Rojas-Gualdron DF, Pericas JM, Benach J. Inequalities in global health inequalities research: A 50-year bibliometric analysis (1966-2015). PLoS One. 2018 Jan 31;13(1):e0191901. doi: 10.1371/journal.pone.0191901. eCollection 2018.

    PubMed 29385197

  • Daley S, Nugent A, Taylor GD. Dental divisions: exploring racial inequities of dental caries amongst children. Evid Based Dent. 2024 Mar;25(1):41-42. doi: 10.1038/s41432-024-00977-w. Epub 2024 Jan 26.

    PubMed 38279035

  • Han C. Oral health disparities: Racial, language and nativity effects. SSM Popul Health. 2019 Jun 21;8:100436. doi: 10.1016/j.ssmph.2019.100436. eCollection 2019 Aug.

    PubMed 31372488

  • Havsed K, Carda-Dieguez M, Isaksson H, Stensson M, Carlsson E, Jansson H, Malmodin D, Nord AB, Wickstrom C, Mira A. Salivary Proteins and Metabolites as Caries Biomarkers in Adolescents. Caries Res. 2024;58(6):573-588. doi: 10.1159/000540090. Epub 2024 Jul 17.

    PubMed 38972309

  • Nath S, Poirier B, Ju X, Kapellas K, Haag D, Jamieson L. Periodontal disease inequities among Indigenous populations: A systematic review and meta-analysis. J Periodontal Res. 2022 Jan;57(1):11-29. doi: 10.1111/jre.12942. Epub 2021 Oct 16.

    PubMed 34655251

  • Nath S, Poirier BF, Ju X, Kapellas K, Haag DG, Ribeiro Santiago PH, Jamieson LM. Dental Health Inequalities among Indigenous Populations: A Systematic Review and Meta-Analysis. Caries Res. 2021;55(4):268-287. doi: 10.1159/000516137. Epub 2021 Jun 9.

    PubMed 34107490

  • Smith PD, Wright W, Hill B. Structural Racism and Oral Health Inequities of Black vs. non-Hispanic White Adults in the U.S. J Health Care Poor Underserved. 2021;32(1):50-63. doi: 10.1353/hpu.2021.0007.

    PubMed 33678680

  • Stojkovic B, Igic M, Jevtovic Stoimenov T, Trickovic Janjic O, Ignjatovic A, Kostic M, Petrovic M, Stojanovic S. Can Salivary Biomarkers Be Used as Predictors of Dental Caries in Young Adolescents? Med Sci Monit. 2020 Jun 10;26:e923471. doi: 10.12659/MSM.923471.

    PubMed 32518218

  • Travassos C, Williams DR. The concept and measurement of race and their relationship to public health: a review focused on Brazil and the United States. Cad Saude Publica. 2004 May-Jun;20(3):660-78. doi: 10.1590/s0102-311x2004000300003. Epub 2004 May 19.

    PubMed 15263977

Questions about this trial

What is this clinical trial studying?

An observational study of Caries,Dental, 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 3 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 20 Feb 2025. 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 Fatma ahmed al safy, Master degree (00201145084182, fatomalsafy@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the patient has caries or not according to ELISA and colorimetric assay (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06838182, which also lists 12 linked publications.

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 20 Feb 2025.

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