Vitamin D DeficiencyNCT05343273
25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III)
An observational study of Vitamin D Deficiency and Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are directly related to periodontal… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Periodontitis
- What is being tested?
- taking a blood sample
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 10 May 2022
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Forty patients with stage 3 periodontitis and 40 healthy volunteers were included in this case-control study at Atatürk University, Department of Dentistry, Department of Periodontology.
Who may be able to join
- Without systemic disease,
- Had a least 14 teeth
Who cannot join
- Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months,
- Individuals with an allergy to any ingredient used in the study,
- Smokers,
- Pregnant or breastfeeding women,
- Using vitamin D,
- Individuals diagnosed with obesity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University
Erzurum, None Selected, 25240
About this study
Official title: Total, Free, and Bioavailable 25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III): A Case-Control Study
Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are directly related to periodontal attachment loss and bone demineralization. These facts suggest that vitamin D may be associated with periodontal disease. Many studies have been conducted on the relationships between serum 25-hydroxyvitamin D (25(OH)D) levels, periodontal disease, and tooth loss. However, as far as we know, there is no study on the relationship between periodontitis and free and bioavailable 25 (OH) vitamin D. In our study, over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis individuals. Serum total 25 (OH) D level and vitamin D binding protein level will be analyzed by ELISA method, and bioavailable 25 (OH) D level will be calculated using total 25 (OH) D and vitamin D binding protein levels. The aim of this study; To evaluate the total, free and bioavailable 25 (OH) vitamin D levels of patients with periodontitis by comparing them with healthy controls, and to investigate whether bioavailable 25 (OH) D plays a role in the pathogenesis of periodontitis or can be a simple marker of disease activity in the light of these findings.
- Conditions
- Vitamin D Deficiency, Periodontitis
- Being tested
- taking a blood sample
- Keywords
- Total 25(OH)D, Bioavailable 25(OH)D, Free 25(OH)D, Periodontitis
- Medical subject headings
- Vitamin D Deficiency, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking a blood sampleDiagnostic test
blood collection for routine biochemical analysis
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Diagnostic Test: taking a blood sample | |
| Periodontitis | Not described Receives: Diagnostic Test: taking a blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of 25(OH)D
Total 25(OH)D levels in serum samples will be measured by ELISA method, using the "Human 25-Dihydroxy vitamin D ELISA Kit" (BT LAB, Cat No: E1981Hu, China) in accordance with the manufacturer's instructions. Results will be recorded in ng/mL.
Measured: Within one week of collecting blood samples from all participants.
Measurements of VDBP
VDBP levels in serum samples will be studied by ELISA (Enzyme Linked Immunosorbend Assay) method using Elabscience brand kit (Elabscience Biotechnology Co., Ltd). Results will be recorded in (ug/mL.
Measured: Within one week of collecting blood samples from all participants.
Measurements of Albumin
Serum albumin levels (g/dL) will be measured on the Roche Cobas c702 instrument (Germany) using commercial kits.
Measured: Within one week of collecting blood samples from all participants.
Calculation of Bioavailable 25(OH)D
It will be calculated using calculations using affinity constants and calculated free 25(OH)D and measured albumin levels.
Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1
Bioavailable 25(OH)D concentration = (6 x 10^5 x [Albumin]+1) x calculated free 25(OH)D
Results will be recorded in ng/mL.
Measured: Within one week of collecting blood samples from all participants.
Calculation of Bioavailable Free 25(OH)D
It will be calculated using calculations using affinity constants and measured total serum 25(OH)D, VDBP and albumin levels.
Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 KVDBP = affinity constant between vitamin D and VDBP = 7 x 10^8 M^-1 [Albumin] = serum albumin concentration = (serum albumin g/L) / 66.430 g/mol [VDBP] = serum vitamin D binding protein concentration = (serum VDBP g/L) / 58.000 g/mol
Free 25(OH)D concentration = Total 25(OH)D / 1+(6 x 10^5 x [Albumin]) + (7 x 10^8 x [VDBP])
Results will be recorded in pg/mL.
Measured: Within one week of collecting blood samples from all participants.
Secondary outcomes (1)
Dental Plaque
Plaque scores recorded by using the Silness\&Löe Plaque Index
PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically.
PI 3: Heavy plaque accumulation is detected at the gin- gival margin and in the interdental spaces.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start10 Mar 2022
- Primary completion30 Apr 2022
- Study completion10 May 2022
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 Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Other
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343273
- Sponsor's protocol ID
- 9099
- Status last verified
- Jun 2022
- First submitted
- 7 Apr 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
Publications
Aydin T, Dilsiz A, Eminoglu DO, Sahin AB, Laloglu E, Bayrakdar YE. Total, free, and bioavailable 25-hydroxyvitamin D levels in patients with periodontitis (stage III): a case-control study. Clin Oral Investig. 2023 Jan;27(1):421-430. doi: 10.1007/s00784-022-04844-9. Epub 2023 Jan 4.
PubMed 36598602
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total, Free, and Bioavailable 25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III): A Case-Control Study
- ClinicalTrials.gov ID
- NCT05343273
- Acronym / sponsor ID
- 9099
- Conditions
- Vitamin D Deficiency, Periodontitis
- Keywords
- Total 25(OH)D, Bioavailable 25(OH)D, Free 25(OH)D, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are directly related to periodontal attachment loss and bone demineralization. These facts suggest that vitamin D may be associated with periodontal disease. Many studies have been conducted on the relationships between serum 25-hydroxyvitamin D (25(OH)D) levels, periodontal disease, and tooth loss. However, as far as we know, there is no study on the relationship between periodontitis and free and bioavailable 25 (OH) vitamin D. In our study, over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis individuals. Serum total 25 (OH) D level and vitamin D binding protein level will be analyzed by ELISA method, and bioavailable 25 (OH) D level will be calculated using total 25 (OH) D and vitamin D binding protein levels. The aim of this study; To evaluate the total, free and bioavailable 25 (OH) vitamin D levels of patients with periodontitis by comparing them with healthy controls, and to investigate whether bioavailable 25 (OH) D plays a role in the pathogenesis of periodontitis or can be a simple marker of disease activity in the light of these findings.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: taking a blood sample |
| Periodontitis | – | Diagnostic Test: taking a blood sample |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Forty patients with stage 3 periodontitis and 40 healthy volunteers were included in this case-control study at Atatürk University, Department of Dentistry, Department of Periodontology.
Key inclusion criteria (2 listed)
- Without systemic disease,
- Had a least 14 teeth
Key exclusion criteria (6 listed)
- Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months,
- Individuals with an allergy to any ingredient used in the study,
- Smokers,
- Pregnant or breastfeeding women,
- Using vitamin D,
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 |
|---|---|---|
| taking a blood sampleblood collection for routine biochemical analysis | Diagnostic test | Healthy, Periodontitis |
Primary outcome
Measurements of 25(OH)D
Time frame: Within one week of collecting blood samples from all participants.
Total 25(OH)D levels in serum samples will be measured by ELISA method, using the "Human 25-Dihydroxy vitamin D ELISA Kit" (BT LAB, Cat No: E1981Hu, China) in accordance with the manufacturer's instructions. Results will be recorded in ng/mL.
Measurements of VDBP
Time frame: Within one week of collecting blood samples from all participants.
VDBP levels in serum samples will be studied by ELISA (Enzyme Linked Immunosorbend Assay) method using Elabscience brand kit (Elabscience Biotechnology Co., Ltd). Results will be recorded in (ug/mL.
Measurements of Albumin
Time frame: Within one week of collecting blood samples from all participants.
Serum albumin levels (g/dL) will be measured on the Roche Cobas c702 instrument (Germany) using commercial kits.
Calculation of Bioavailable 25(OH)D
Time frame: Within one week of collecting blood samples from all participants.
It will be calculated using calculations using affinity constants and calculated free 25(OH)D and measured albumin levels. Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 Bioavailable 25(OH)D concentration = (6 x 10^5 x [Albumin]+1) x calculated free 25(OH)D Results will be recorded in ng/mL.
Calculation of Bioavailable Free 25(OH)D
Time frame: Within one week of collecting blood samples from all participants.
It will be calculated using calculations using affinity constants and measured total serum 25(OH)D, VDBP and albumin levels. Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 KVDBP = affinity constant between vitamin D and VDBP = 7 x 10^8 M^-1 [Albumin] = serum albumin concentration = (serum albumin g/L) / 66.430 g/mol [VDBP] = serum vitamin D binding protein concentration = (serum VDBP g/L) / 58.000 g/mol Free 25(OH)D concentration = Total 25(OH)D / 1+(6 x 10^5 x [Albumin]) + (7 x 10^8 x [VDBP]) Results will be recorded in pg/mL.
1 secondary outcome
Dental Plaque
Time frame: Day 1
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 Jun 2022.
- Derived from this study: PubMed 36598602Aydin T, Dilsiz A, Eminoglu DO, Sahin AB, Laloglu E, Bayrakdar YE. Total, free, and bioavailable 25-hydroxyvitamin D levels in patients with periodontitis (stage III): a case-control study. Clin Oral Investig. 2023 Jan;27(1):421-430. doi: 10.1007/s00784-022-04844-9. Epub 2023 Jan 4.
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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.
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 Vitamin D Deficiency and Periodontitis, run by Ataturk University 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 6 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 Jun 2022. 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?
Measurements of 25(OH)D (time frame: Within one week of collecting blood samples from all participants.). The study lists 5 primary outcomes in all. 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 NCT05343273, 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 3 Jun 2022.