Clinical trial NCT06343766: Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.
Official title: Polymorphisms in ENAM, AMBN, and KLK4 Predispose Egyptian Adults to Dental Caries: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries Secondary to Polymorphisms
Polymorphisms in Enamel Encoding Genes
Keywords: Enamelin (ENAM)
Ameloblastin (AMBN)
Tuftelin 1 (TUFT1)
Kallikrein-related peptidase-4 (KLK4)
Dental caries
Polymorphisms
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 204
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility.
timeFrame: Done immediately following completion of assessment for eligibility of enrolment in the present study
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, October 6 University
Study officials:
affiliation: Faculty of Dentistry, October 6 University, Giza, Egypt; +201222323200; Hassannegm.dent@o6u.edu.eg
name: Hassan M. Negm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, October 6 University, Giza, Egypt; rania.rashad@dentistry.cu.edu.eg
name: Rania R. Omar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, October 6 University, Giza, Egypt; AminaFouadFarag.dent@o6u.edu.eg
name: Amina F. Farag, PhD
role: PRINCIPAL_INVESTIGATOR
References: