PeriodontitisNCT04806971
Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms in Periodontitis
An observational study of Periodontitis and Polymorphism, Restriction Fragment Length, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Polymorphism, Restriction Fragment Length
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 29 Jan 2018to 27 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 200 subjects were recruited from the Marmara University, Faculty of Dentistry, Clinics of Periodontology
Who may be able to join
- systemically healthy, previously untreated periodontitis patients
Who cannot join
- presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Marmara University
Istanbul, Maltepe, 34854
Marmara University Dental Faculty Periodontology Department
Istanbul
About this study
Official title: Association Between Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms and Stage III Grade B/C Periodontitis
Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis.
Methods: Individuals who were found to be systemically and periodontally healthy (N = 100) after clinical and radiographic examination and who were diagnosed with Stage III Grade B / C periodontitis (N = 100) were included in the study. Gingival index, Plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with Real Time Polymerase Chain Reaction.
Read the detailed description
In this study we recruited 200 participants from the Periodontology Clinics. Periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. Genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by Real Time Polymerase Chain Reaction.Statistical analysis was done by the statistical software package SPSS v16. SNPassoc.
- Keywords
- Vitamin D receptor, Polymorphism, Periodontitis,, Interleukin-1B, Interleukin-1A
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Patients with grade B / C, stage III periodontitis were classified based on the new classification criteria.Clinical attachment loss ≥5 mm, probing depth (PD) ≥6 mm, ≥20 teeth and radiographic bone loss extending to the root middle third. Grade was assessed considering the radiographic bone loss in the most affected tooth in the dentition as a function of age (Grade B=0.25-1.0, Grade C= >1.0). | |
| Healthy | The periodontally healthy subjects without any clinical sign of inflammation,not showing a history of periodontitis; PD ≤3 mm; <10% of sites with BOP; an absence of detectable bone loss and/or attachment ; without extensive caries or restorations and presence of at least 28 permanent teeth. In addition, all the control subjects showed the absence of any local or systemic pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1A gene polymorphism
Measured: baseline
Interleukin-1B gene polymorphism
Measured: baseline
Vitamin D Receptor gene polymorphism
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start29 Jan 2018
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806971
- Sponsor's protocol ID
- SAG-K-170118-0002
- Status last verified
- Nov 2021
- First submitted
- 16 Mar 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms and Stage III Grade B/C Periodontitis
- ClinicalTrials.gov ID
- NCT04806971
- Acronym / sponsor ID
- SAG-K-170118-0002
- Keywords
- Vitamin D receptor, Polymorphism, Periodontitis,, Interleukin-1B, Interleukin-1A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 19 Mar 2021 (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.
Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis.
Methods: Individuals who were found to be systemically and periodontally healthy (N = 100) after clinical and radiographic examination and who were diagnosed with Stage III Grade B / C periodontitis (N = 100) were included in the study. Gingival index, Plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with Real Time Polymerase Chain Reaction.
Detailed description
In this study we recruited 200 participants from the Periodontology Clinics. Periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. Genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by Real Time Polymerase Chain Reaction.Statistical analysis was done by the statistical software package SPSS v16. SNPassoc.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | –Patients with grade B / C, stage III periodontitis were classified based on the new classification criteria.Clinical attachment loss ≥5 mm, probing depth (PD) ≥6 mm, ≥20 teeth and radiographic bone loss extending to the root middle third. Grade was assessed considering the radiographic bone loss in the most affected tooth in the dentition as a function of age (Grade B=0.25-1.0, Grade C= >1.0). |
| Healthy | – | –The periodontally healthy subjects without any clinical sign of inflammation,not showing a history of periodontitis; PD ≤3 mm; <10% of sites with BOP; an absence of detectable bone loss and/or attachment ; without extensive caries or restorations and presence of at least 28 permanent teeth. In addition, all the control subjects showed the absence of any local or systemic pathology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 subjects were recruited from the Marmara University, Faculty of Dentistry, Clinics of Periodontology
Key inclusion criteria (1 listed)
- systemically healthy, previously untreated periodontitis patients
Key exclusion criteria (1 listed)
- presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-1A gene polymorphism
Time frame: baseline
Interleukin-1B gene polymorphism
Time frame: baseline
Vitamin D Receptor gene polymorphism
Time frame: baseline
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 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Polymorphism, Restriction Fragment Length, run by Marmara University at 2 sites 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 1 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
IL-1A gene polymorphism (time frame: baseline). The study lists 3 primary outcomes in all. 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 15 Dec 2021.