Dental Caries Secondary to PolymorphismsNCT06343766
Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.
An observational study of Dental Caries Secondary to Polymorphisms and Polymorphisms in Enamel Encoding Genes, run by Amina Fouad Farag at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Secondary to Polymorphisms, Polymorphisms in Enamel Encoding Genes
- What is being tested?
- DNA collation and genotyping
- How many people
- 204 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Nov 2022to 5 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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)
Who cannot join
- The presence of white spots or fluorosis, indicating enamel defects or demineralization, required exclusion from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- DNA collation and genotyping
- Keywords
- Enamelin (ENAM), Ameloblastin (AMBN), Tuftelin 1 (TUFT1), Kallikrein-related peptidase-4 (KLK4), Dental caries, Polymorphisms
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA collation and genotypingGenetic
Also called Dental examinations
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Caries-susceptible group Receives: Genetic: DNA collation and genotyping | |
| Control group | Caries-resistant group Receives: Genetic: DNA collation and genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility.
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
Measured: Done immediately following completion of assessment for eligibility of enrolment in the present study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start6 Nov 2022
- Primary completion5 Nov 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Secondary to PolymorphismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amina Fouad Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amina Fouad Farag, October 6 University
- Investigators
- Hassan M. Negm, PhD, Principal investigator, Faculty of Dentistry, October 6 University, Giza, Egypt; +201222323200; Hassannegm.dent@o6u.edu.egRania R. Omar, PhD, Principal investigator, Faculty of Dentistry, October 6 University, Giza, Egypt; rania.rashad@dentistry.cu.edu.egAmina F. Farag, PhD, Principal investigator, Faculty of Dentistry, October 6 University, Giza, Egypt; AminaFouadFarag.dent@o6u.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343766
- Sponsor's protocol ID
- RECO6U/24-2022
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms in ENAM, AMBN, and KLK4 Predispose Egyptian Adults to Dental Caries: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06343766
- Acronym / sponsor ID
- RECO6U/24-2022
- Keywords
- Enamelin (ENAM), Ameloblastin (AMBN), Tuftelin 1 (TUFT1), Kallikrein-related peptidase-4 (KLK4), Dental caries, Polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Amina Fouad FaragUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Genetic: DNA collation and genotypingCaries-susceptible group |
| Control group | – | Genetic: DNA collation and genotypingCaries-resistant group |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- The presence of white spots or fluorosis, indicating enamel defects or demineralization, required exclusion from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA collation and genotypingAlso: Dental examinationsDNA 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. | Genetic | Control group, Experimental group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan M. Negm, PhD principal investigator
Faculty of Dentistry, October 6 University, Giza, Egypt; +201222323200; Hassannegm.dent@o6u.edu.eg
Rania R. Omar, PhD principal investigator
Faculty of Dentistry, October 6 University, Giza, Egypt; rania.rashad@dentistry.cu.edu.eg
Amina F. Farag, PhD principal investigator
Faculty of Dentistry, October 6 University, Giza, Egypt; AminaFouadFarag.dent@o6u.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries Secondary to Polymorphisms and Polymorphisms in Enamel Encoding Genes, run by Amina Fouad Farag at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.