High Caries RiskNCT04066101
TAS1R1, TAS1R3, TLR2, TLR4, CA6 Gene Polymorphism on Dental Caries
An observational study of High Caries Risk and Low Caries Risk, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of TAS1R1, TAS1R3, TLR2, TLR4, CA6, gene polymorphism on caries risk in adults. Read more about this study
- Who is it for?
- Ages 25 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk, Low Caries Risk
- What is being tested?
- high caries risk and caries activity
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2018to 20 Nov 2019
- 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 25 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Power analysis was performed with the G-Power software package. It was determined that a total of 200 patients will be needed: 100 (DMFT ≤ 5) for the low caries risk group and 100 (DMFT ≥ 14) for the high caries risk group
Who may be able to join
- adult be between 25 and 44 years old
- subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) ≥ 5, or, DMFT ≥14
- same oral health, diet and socioeconomic status
Who cannot join
- systemic or genetic disorders
- orthodontic appliances
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variants in Taste Genes on Caries Risk and Caries Activity Status
The aim of this study is to examine the effects of TAS1R1, TAS1R3, TLR2, TLR4, CA6, gene polymorphism on caries risk 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.
CA6 exists in the human saliva and has a critical role of buffering, immune response and taste.Toll-like receptors are expressed in the tongue gustatory papillae where they may initiate immune responses to pathogens.Genetic variations in the TAS1R1 and TAS1R3 for umami cause perception of these tastes differently.
- Conditions
- High Caries Risk, Low Caries Risk
- Being tested
- high caries risk, caries activity
- Keywords
- caries risk, gene polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high caries riskGenetic
Also called DNA isolation, genotyping
DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit Genotyping for a variant was carried out on a Roche Applied Science LightCycler® 480 (Roche Diagnostics GmbH, Mannheim, Germany) with real-time polymerase reaction of Taqman
caries activityOther
Dental caries lesions of all patient scored as initial, moderate or advanced caries
Initial lesion; clinically detectable lesion Moderate; visible signs of enamel breakdown Advanced; enamel was fully cavitaed
| Study group | Role | What they receive |
|---|---|---|
| high caries risk | 100 adults will be allowed in the high caries risk group according to DMFT index (DMFT ≥ 14) Receives: Genetic: high caries risk; Other: caries activity | |
| low caries risk | 100 adults will be allowed in the low caries risk group according to DMFT index (DMFT ≤ 5) Receives: Genetic: high caries risk; Other: caries activity |
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 (DMFT). Caries will be defined in accordance with the World Health Organization (WHO 1997) criteria.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start15 Jan 2018
- Primary completion15 Oct 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Caries RiskStudies 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
- 200 participants (actual)
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
- NCT04066101
- Sponsor's protocol ID
- 2016/30
- Status last verified
- Apr 2021
- First submitted
- 21 Aug 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available within 6 months of study completion
Publications
Yildiz G, Ermis RB, Calapoglu NS, Celik EU, Turel GY. Gene-environment Interactions in the Etiology of Dental Caries. J Dent Res. 2016 Jan;95(1):74-9. doi: 10.1177/0022034515605281. Epub 2015 Sep 16.
PubMed 26377569Yildiz Telatar G, Saydam F, Guzel AI, Telatar BC. Variants in taste genes on caries risk and caries activity status. Med Mol Morphol. 2020 Dec;53(4):244-251. doi: 10.1007/s00795-020-00263-5. Epub 2020 Aug 7.
PubMed 32770263
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
- Variants in Taste Genes on Caries Risk and Caries Activity Status
- ClinicalTrials.gov ID
- NCT04066101
- Acronym / sponsor ID
- 2016/30
- Conditions
- High Caries Risk, Low Caries Risk
- Keywords
- caries risk, gene polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 26 Aug 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.
The aim of this study is to examine the effects of TAS1R1, TAS1R3, TLR2, TLR4, CA6, gene polymorphism on caries risk 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.
CA6 exists in the human saliva and has a critical role of buffering, immune response and taste.Toll-like receptors are expressed in the tongue gustatory papillae where they may initiate immune responses to pathogens.Genetic variations in the TAS1R1 and TAS1R3 for umami cause perception of these tastes differently.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high caries risk | – | Genetic: high caries risk, Other: caries activity100 adults will be allowed in the high caries risk group according to DMFT index (DMFT ≥ 14) |
| low caries risk | – | Genetic: high caries risk, Other: caries activity100 adults will be allowed in the low caries risk group according to DMFT index (DMFT ≤ 5) |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Power analysis was performed with the G-Power software package. It was determined that a total of 200 patients will be needed: 100 (DMFT ≤ 5) for the low caries risk group and 100 (DMFT ≥ 14) for the high caries risk group
Key inclusion criteria (3 listed)
- adult be between 25 and 44 years old
- subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) ≥ 5, or, DMFT ≥14
- same oral health, diet and socioeconomic status
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 riskAlso: DNA isolation, genotypingDNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit Genotyping for a variant was carried out on a Roche Applied Science LightCycler® 480 (Roche Diagnostics GmbH, Mannheim, Germany) with real-time polymerase reaction of Taqman | Genetic | high caries risk, low caries risk |
| caries activityDental caries lesions of all patient scored as initial, moderate or advanced caries Initial lesion; clinically detectable lesion Moderate; visible signs of enamel breakdown Advanced; enamel was fully cavitaed | Other | high caries risk, low caries risk |
Primary outcome
Past caries experience
Time frame: 4 months
Each tooth will be examined and recorded as decayed, missing, or filled (DMFT). Caries will be defined in accordance with the World Health Organization (WHO 1997) criteria.
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 26377569Yildiz G, Ermis RB, Calapoglu NS, Celik EU, Turel GY. Gene-environment Interactions in the Etiology of Dental Caries. J Dent Res. 2016 Jan;95(1):74-9. doi: 10.1177/0022034515605281. Epub 2015 Sep 16.
- Derived from this study: PubMed 32770263Yildiz Telatar G, Saydam F, Guzel AI, Telatar BC. Variants in taste genes on caries risk and caries activity status. Med Mol Morphol. 2020 Dec;53(4):244-251. doi: 10.1007/s00795-020-00263-5. Epub 2020 Aug 7.
- Gene-environment Interactions in the Etiology of Dental Caries.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available within 6 months of study completion
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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 High Caries Risk and Low Caries Risk, 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 3 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: 4 months). 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 NCT04066101, which also lists 2 linked publications.
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.