Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.

March 26, 2024 updated by: Amina Fouad Farag

Polymorphisms in ENAM, AMBN, and KLK4 Predispose Egyptian Adults to Dental Caries: A Cross-Sectional Study

A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research investigates the distributional discrepancies of specific polymorphic loci ENAM rs3796703, AMBN rs4694075, TUFT1 rs13236243, and KLK4 rs2242670-within the Egyptian population as correlatives and causatives of dental caries susceptibility through the genotyping of enamelin (ENAM rs3796703), ameloblastin (AMBN rs4694075), tuftelin 1 (TUFT1 rs78802584), and kallikrein 4 (KLK4 rs2242670) in 132 adults (males = 74, females = 58) and 72 controls (males = 40, females = 32) referred from various Egyptian hospitals. For each participant, the number of decayed, missing, and filled teeth was charted, and the presence of biofilm/gingivitis/fluorosis was assessed. Bitewing radiographs were taken to detect interproximal caries. In addition, statistical analysis was conducted using Chi-square test, odds ratios, and corresponding P-values.

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12511
        • Faculty of Dentistry, October 6 University

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients presented to Operative Dentistry Department, Faculty of Dentistry and Outpatient Clinics of University Hospital of October 6 University and referred from various Egyptian hospitals in Greater Cairo, Egypt

Description

Inclusion Criteria:

  • Presence of dental caries or decay in form of discoloration, cavities, or visible enamel softening suggestive of potential caries (Caries-susceptible group)
  • Caries-free patients as control group (Caries-resistant group)

Exclusion Criteria:

  • The presence of white spots or fluorosis, indicating enamel defects or demineralization, required exclusion from the study.

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
Experimental group
Caries-susceptible group
Genetic: DNA collation and genotyping

DNA collation and genotyping of specific genes ENAM rs3796703, AMBN rs4694075), TUFT1 rs78802584 and KLK4 rs2242670 through PCR and sequencing for various SNPs

Dental examinations by comparing dental covariates such as the number of DMF-T index, presence of biofilm, gingivitis, fluorosis, and detection of interproximal caries with caries progression.

Other Names:
  • Dental examinations
Control group
Caries-resistant group
Genetic: DNA collation and genotyping

DNA collation and genotyping of specific genes ENAM rs3796703, AMBN rs4694075), TUFT1 rs78802584 and KLK4 rs2242670 through PCR and sequencing for various SNPs

Dental examinations by comparing dental covariates such as the number of DMF-T index, presence of biofilm, gingivitis, fluorosis, and detection of interproximal caries with caries progression.

Other Names:
  • Dental examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility.
Time Frame: Done immediately following completion of assessment for eligibility of enrolment in the present study
Potential role of alleles or genotypes of enamel encoding genes such as ENAM, AMBN, TUFT1 and KLK4 in the caries-susceptible group and in the caries-resistant group using PCR and sequencing for various SNPs
Done immediately following completion of assessment for eligibility of enrolment in the present study

Collaborators and Investigators

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

Sponsor

Amina Fouad Farag

Investigators

  • Principal Investigator: Hassan M. Negm, PhD, Faculty of Dentistry, October 6 University, Giza, Egypt; +201222323200; Hassannegm.dent@o6u.edu.eg
  • Principal Investigator: Rania R. Omar, PhD, Faculty of Dentistry, October 6 University, Giza, Egypt; rania.rashad@dentistry.cu.edu.eg
  • Principal Investigator: Amina F. Farag, PhD, Faculty of Dentistry, October 6 University, Giza, Egypt; AminaFouadFarag.dent@o6u.edu.eg

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 (Actual)

November 6, 2022

Primary Completion (Actual)

November 5, 2023

Study Completion (Actual)

November 5, 2023

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECO6U/24-2022

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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