NCT06838182

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

28 days

First QC Date

February 11, 2025

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (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 )

    3 months

Study Arms (2)

caries free

Diagnostic Test: Salivary biomarkers tests

CARIES EXPERINCED

Diagnostic Test: Salivary biomarkers tests

Interventions

saliva samples are collected from participants

CARIES EXPERINCEDcaries free

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

different races : Asian , African , Indian .

You may qualify if:

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

You may not qualify if:

  • : 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 26622284BACKGROUND
  • 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.

    PMID: 28723991BACKGROUND
  • 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.

    PMID: 29104292BACKGROUND
  • 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.

    PMID: 29385197BACKGROUND
  • 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.

    PMID: 38279035BACKGROUND
  • 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.

    PMID: 31372488BACKGROUND
  • 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.

    PMID: 38972309BACKGROUND
  • 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.

    PMID: 34655251BACKGROUND
  • 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.

    PMID: 34107490BACKGROUND
  • 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.

    PMID: 33678680BACKGROUND
  • 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.

    PMID: 32518218BACKGROUND
  • 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.

    PMID: 15263977BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Fatma ahmed al safy, Master degree

CONTACT

shereen hafez ibrahim, phd

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator , researcher , data enterer and writing the research

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 20, 2025

Study Start

February 25, 2025

Primary Completion

March 25, 2025

Study Completion

April 25, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02