Low Caries ExperienceNCT04124718
VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults
An observational study of Low Caries Experience and High Caries Experience, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Caries Experience, High Caries Experience
- What is being tested?
- high caries experience
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2019to 10 Feb 2020
- How long will I take part?
- 1 Week
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study
Who may be able to join
- adult be between 24 and 40 years old
- subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT>13.9
Who cannot join
- systemic or genetic disorders
- orthodontic appliances
- pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Dentistry Faculty
Rize, 53000
About this study
Official title: 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.
Read the 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
- Conditions
- Low Caries Experience, High Caries Experience
- Being tested
- high caries experience
- Keywords
- caries experience, VDR, TFIP11, enviromental risk factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caries experienceGenetic
Also called DNA isolation, genotyping
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
| Study group | Role | What they receive |
|---|---|---|
| high caries experience | 80 adults will be allowed in the high caries experience group according to DMFT index DMFT>13.9 Receives: Genetic: high caries experience | |
| low caries experience | 80 adults will be allowed in the high caries experience group according toDMFT index DMFT≤4 Receives: Genetic: high caries experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
past caries experience
Each tooth will be examined and recorded as decayed, missing, or filled
Measured: 3 weeks
Secondary outcomes (1)
Plaque index
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start26 Dec 2019
- Primary completion26 Jan 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Caries ExperienceStudies 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
- Cross-sectional
- Enrolment
- 160 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Gül Yıldız Telatar, dr, Principal investigator, Recep Tayyip Erdogan University Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124718
- Sponsor's protocol ID
- 2019-204
- Status last verified
- Apr 2021
- First submitted
- 10 Oct 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be available within 6 months of study completion
Publications
Cogulu D, Onay H, Ozdemir Y, Aslan GI, Ozkinay F, Eronat C. The Role of Vitamin D Receptor Polymorphisms on Dental Caries. J Clin Pediatr Dent. 2016;40(3):211-4. doi: 10.17796/1053-4628-40.3.211.
PubMed 27472568
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Enamel Gene Variants and Dental Caries in Adults
- ClinicalTrials.gov ID
- NCT04124718
- Acronym / sponsor ID
- 2019-204
- Conditions
- Low Caries Experience, High Caries Experience
- Keywords
- caries experience, VDR, TFIP11, enviromental risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Oct 2019 (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.
VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high caries experience | – | Genetic: high caries experience80 adults will be allowed in the high caries experience group according to DMFT index DMFT>13.9 |
| low caries experience | – | Genetic: high caries experience80 adults will be allowed in the high caries experience group according toDMFT index DMFT≤4 |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study
Key inclusion criteria (2 listed)
- adult be between 24 and 40 years old
- subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT>13.9
Key exclusion criteria (3 listed)
- systemic or genetic disorders
- orthodontic appliances
- pregnant women
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 |
|---|---|---|
| high caries experienceAlso: DNA isolation, genotypingDNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit | Genetic | high caries experience, low caries experience |
Primary outcome
past caries experience
Time frame: 3 weeks
Each tooth will be examined and recorded as decayed, missing, or filled
1 secondary outcome
Plaque index
Time frame: 3 weeks
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 15 Apr 2021.
- Background: PubMed 27472568Cogulu D, Onay H, Ozdemir Y, Aslan GI, Ozkinay F, Eronat C. The Role of Vitamin D Receptor Polymorphisms on Dental Caries. J Clin Pediatr Dent. 2016;40(3):211-4. doi: 10.17796/1053-4628-40.3.211.
- The Role of Vitamin D Receptor Polymorphisms on Dental Caries.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available within 6 months of study completion
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.
Gül Yıldız Telatar, dr principal investigator
Recep Tayyip Erdogan University Dentistry Faculty
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 Low Caries Experience and High Caries Experience, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 15 Apr 2021. 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 Turkey (Türkiye). 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?
past caries experience (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124718, which also lists 1 linked publication.
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 15 Apr 2021.