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Completed

NCT Number: NCT06343766

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

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.

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Key information

Age range

15 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, October 6 University

Giza, 12511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DNA collation and genotyping

Genetic

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Amina Fouad Farag

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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