- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124718
VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults
April 12, 2021 updated by: Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital
Association Between Enamel Gene Variants and Dental Caries in Adults
VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To date, genes can be grouped into categories based on the factor influencing dental caries. The major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits.
TFIP11 and VDR genes are related to enamel formation genes
Study Type
Observational
Enrollment (Actual)
160
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
-
-
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Rize, Turkey, 53000
- Recep Tayyip Erdogan University Dentistry Faculty
-
-
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
24 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study
Description
Inclusion Criteria:
- adult be between 24 and 40 years old
- subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT>13.9
Exclusion Criteria:
- systemic or genetic disorders
- orthodontic appliances
- pregnant women
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 |
---|---|
high caries experience
80 adults will be allowed in the high caries experience group according to DMFT index DMFT>13.9
|
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
Other Names:
|
low caries experience
80 adults will be allowed in the high caries experience group according toDMFT index DMFT≤4
|
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
past caries experience
Time Frame: 3 weeks
|
Each tooth will be examined and recorded as decayed, missing, or filled
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque index
Time Frame: 3 weeks
|
The plaque amount is scored by using Silness&Löe Plaque Index plaque index PI<1.0
healthy PI 1.1-2.0
mild PI>2 high plaque
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 26, 2019
Primary Completion (Actual)
January 26, 2020
Study Completion (Actual)
February 10, 2020
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (Actual)
October 11, 2019
Study Record Updates
Last Update Posted (Actual)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2019-204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be available within 6 months of study completion
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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