D Vitamin DeficiencyNCT06871631
Serum Vitamin D and Gingival Crevicular Fluid Levels of Osteocalcin and N-Terminal Telopeptide
An observational study of D Vitamin Deficiency and Osteocalcin, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study examines the relationship between serum vitamin D levels and bone metabolism markers-osteocalcin and N-terminal telopeptide (NTx)-in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- D Vitamin Deficiency, Osteocalcin, Gingival Crevicular Fluid
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2018to 15 Feb 2025
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Study participants will be selected from individuals seeking care at the Department of Periodontology, Faculty of Dentistry, and the Department of Endocrinology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey. The population includes adults with varying periodontal and vitamin D statuses, including periodontally healthy individuals and those with periodontitis. Participants represent a diverse clinical population from the surrounding region and are recruited based on their eligibility for the study's objectives, particularly in relation to serum vitamin D levels and bone metabolism markers in gingival crevicular fluid.
Who may be able to join
- One hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years, non-smoking, who had not received periodontal treatment in the last 6 months, with no systemic diseases, and whose Vitamin D levels had been determined, were included in the study.
Who cannot join
- Female individuals
- Smokers
- Individuals with systemic diseases (Diabetes Mellitus, Hyperthyroidism, -Malabsorption, Liver and Renal Failure, or those receiving osteoporosis treatment)
- Individuals who have undergone periodontal treatment within the last 6 months
- Individuals on regular medication
- Individuals who did not provide informed consent
- Individuals with poor cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University
Samsun, Atakum, 55200
About this study
Official title: Relationships Between Serum Vitamin D Levels and Osteocalcin and N-terminal Telopeptide Levels in Gingival Crevicular Fluid
This study examines the relationship between serum vitamin D levels and bone metabolism markers-osteocalcin and N-terminal telopeptide (NTx)-in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients. A total of 120 male participants (60 healthy, 60 with periodontitis) aged 25-40 were included and categorized based on their serum vitamin D levels.
Read the detailed description
Recent evidence suggests that vitamin D, a key regulator of bone metabolism, may play a role in periodontal health by influencing bone turnover markers such as osteocalcin and N-terminal telopeptide (NTx). This study aims to investigate the effects of serum vitamin D levels on these bone metabolism markers in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients.
A total of 120 male participants aged 25-40 years were enrolled, comprising 60 periodontally healthy individuals and 60 patients diagnosed with periodontitis. Participants were further categorized into subgroups based on their serum vitamin D levels (0-10 ng/ml, 11-20 ng/ml, and 21-30 ng/ml). GCF samples were collected from maxillary premolar and molar sites and analyzed using enzyme-linked immunosorbent assay (ELISA) to measure osteocalcin and NTx concentrations.
- Conditions
- D Vitamin Deficiency, Osteocalcin, Gingival Crevicular Fluid
- Keywords
- Vitamin D, Osteocalcin, N-Terminal Telopeptide, Gingival Crevicular Fluid
- Medical subject headings
- Vitamin D Deficiency
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 |
|---|---|---|
| Patients with periodontitis and 25(OH)D levels of 0-10 ng/ml | Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 0 to 10 ng/ml. | |
| Patients with periodontitis and 25(OH)D levels of 11-20 ng/ml | Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 11 to 20 ng/ml. | |
| Patients with periodontitis and 25(OH)D levels of 21-30 ng/ml | Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 21 to 30 ng/ml. | |
| Periodontally healthy patients and 25(OH)D levels of 0-10 ng/ml | Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 0 and 10 ng/ml. | |
| Periodontally healthy patients and 25(OH)D levels of 11-20 ng/ml | Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 11 and 20 ng/ml. | |
| Periodontally healthy patients and 25(OH)D levels of 21-30 ng/ml | Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 21 and 30 ng/ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)
Osteocalcin concentration will be determined using an enzyme-linked immunosorbent assay (ELISA) and expressed in ng/mL.
Measured: At baseline (single time point)
N-Terminal Telopeptide Concentration in Gingival Crevicular Fluid (nmol/L)
NTx concentration will be measured using an ELISA and expressed in nmol/L.
Measured: At baseline (single time point)
Total Osteocalcin Levels in Gingival Crevicular Fluid (ng/ml)
This measure assesses the total osteocalcin amount in gingival crevicular fluid. Absorbance values will be recorded using an ELISA reader, and total levels will be determined based on a standard curve.
Measured: At baseline (single time point)
Total N-Terminal Telopeptide Levels in Gingival Crevicular Fluid (nmol/L)
This measure quantifies the total amount of N-Terminal Telopeptide in gingival crevicular fluid. The total amount is determined using ELISA and calculated based on a standard curve.
Measured: At baseline (single time point)
Secondary outcomes (4)
Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluid
This outcome measure evaluates the correlation between serum vitamin D levels and osteocalcin and N-terminal telopeptide levels in gingival crevicular fluid across different vitamin D ranges and periodontal health statuses. Serum vitamin D levels will be categorized into three groups: 0-10 ng/mL, 11-20 ng/mL, and 21-30 ng/mL. Participants will be classified as periodontally healthy or having periodontitis based on clinical periodontal assessments.
Measured: At baseline (single time point)
Periodontal clinical parameters (probing depth)
Probing depth of ≤3 mm was recorded as within the normal healthy range, while ≥5 mm was considered unhealthy
Measured: At baseline (single time point)
Periodontal clinical parameters (bleeding on probing)
Bleeding on probing (BoP) <10% was considered within the healthy range, while ≥10% was classified as unhealthy.
Measured: At baseline (single time point)
Periodontal clinical parameters (clinical attachment level)
Clinical attachment level (CAL) was assessed based on probing depth (PD) and gingival recession, with measurements taken from the cementoenamel junction (CEJ) to the base of the pocket. Radiographic bone loss was also evaluated to confirm attachment loss and periodontal status.
Measured: At baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start10 Jun 2018
- Primary completion17 Apr 2022
- Study completion15 Feb 2025
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 D Vitamin DeficiencyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atanur Sarioglu, Ondokuz Mayıs University
- Investigators
- Atanur Sarioglu, DDS, Principal investigator, Ondokuz Mayıs University, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871631
- Sponsor's protocol ID
- OMU KAEK protokol no: 2017/60
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.
Publications
Cevik B, Sarioglu A, Kirtiloglu T, Avci B, Tomak L. Association between serum vitamin D3 levels and gingival crevicular fluid osteocalcin and N-terminal telopeptide levels in periodontal health and disease. J Appl Oral Sci. 2026 Aug 3;34:e20260009. doi: 10.1590/1678-7765-2026-0009. eCollection 2026.
PubMed 42561211
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Serum Vitamin D Levels and Osteocalcin and N-terminal Telopeptide Levels in Gingival Crevicular Fluid
- ClinicalTrials.gov ID
- NCT06871631
- Acronym / sponsor ID
- OMU KAEK protokol no: 2017/60
- Conditions
- D Vitamin Deficiency, Osteocalcin, Gingival Crevicular Fluid
- Keywords
- Vitamin D, Osteocalcin, N-Terminal Telopeptide, Gingival Crevicular Fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 12 Mar 2025 (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.
This study examines the relationship between serum vitamin D levels and bone metabolism markers-osteocalcin and N-terminal telopeptide (NTx)-in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients. A total of 120 male participants (60 healthy, 60 with periodontitis) aged 25-40 were included and categorized based on their serum vitamin D levels.
Detailed description
Recent evidence suggests that vitamin D, a key regulator of bone metabolism, may play a role in periodontal health by influencing bone turnover markers such as osteocalcin and N-terminal telopeptide (NTx). This study aims to investigate the effects of serum vitamin D levels on these bone metabolism markers in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients.
A total of 120 male participants aged 25-40 years were enrolled, comprising 60 periodontally healthy individuals and 60 patients diagnosed with periodontitis. Participants were further categorized into subgroups based on their serum vitamin D levels (0-10 ng/ml, 11-20 ng/ml, and 21-30 ng/ml). GCF samples were collected from maxillary premolar and molar sites and analyzed using enzyme-linked immunosorbent assay (ELISA) to measure osteocalcin and NTx concentrations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with periodontitis and 25(OH)D levels of 0-10 ng/ml | – | –Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 0 to 10 ng/ml. |
| Patients with periodontitis and 25(OH)D levels of 11-20 ng/ml | – | –Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 11 to 20 ng/ml. |
| Patients with periodontitis and 25(OH)D levels of 21-30 ng/ml | – | –Patients diagnosed with periodontitis who have serum 25-hydroxyvitamin D [25(OH)D] levels ranging from 21 to 30 ng/ml. |
| Periodontally healthy patients and 25(OH)D levels of 0-10 ng/ml | – | –Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 0 and 10 ng/ml. |
| Periodontally healthy patients and 25(OH)D levels of 11-20 ng/ml | – | –Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 11 and 20 ng/ml. |
| Periodontally healthy patients and 25(OH)D levels of 21-30 ng/ml | – | –Periodontally healthy patients with serum 25-hydroxyvitamin D [25(OH)D] levels between 21 and 30 ng/ml. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants will be selected from individuals seeking care at the Department of Periodontology, Faculty of Dentistry, and the Department of Endocrinology, Faculty of Medicine, Ondokuz Mayis University, Samsun, Turkey. The population includes adults with varying periodontal and vitamin D statuses, including periodontally healthy individuals and those with periodontitis. Participants represent a diverse clinical population from the surrounding region and are recruited based on their eligibility for the study's objectives, particularly in relation to serum vitamin D levels and bone metabolism markers in gingival crevicular fluid.
Key inclusion criteria (1 listed)
- One hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years, non-smoking, who had not received periodontal treatment in the last 6 months, with no systemic diseases, and whose Vitamin D levels had been determined, were included in the study.
Key exclusion criteria (7 listed)
- Female individuals
- Smokers
- Individuals with systemic diseases (Diabetes Mellitus, Hyperthyroidism, -Malabsorption, Liver and Renal Failure, or those receiving osteoporosis treatment)
- Individuals who have undergone periodontal treatment within the last 6 months
- Individuals on regular medication
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
Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)
Time frame: At baseline (single time point)
Osteocalcin concentration will be determined using an enzyme-linked immunosorbent assay (ELISA) and expressed in ng/mL.
N-Terminal Telopeptide Concentration in Gingival Crevicular Fluid (nmol/L)
Time frame: At baseline (single time point)
NTx concentration will be measured using an ELISA and expressed in nmol/L.
Total Osteocalcin Levels in Gingival Crevicular Fluid (ng/ml)
Time frame: At baseline (single time point)
This measure assesses the total osteocalcin amount in gingival crevicular fluid. Absorbance values will be recorded using an ELISA reader, and total levels will be determined based on a standard curve.
Total N-Terminal Telopeptide Levels in Gingival Crevicular Fluid (nmol/L)
Time frame: At baseline (single time point)
This measure quantifies the total amount of N-Terminal Telopeptide in gingival crevicular fluid. The total amount is determined using ELISA and calculated based on a standard curve.
4 secondary outcomes
Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluid
Time frame: At baseline (single time point)
Periodontal clinical parameters (probing depth)
Time frame: At baseline (single time point)
Periodontal clinical parameters (bleeding on probing)
Time frame: At baseline (single time point)
Periodontal clinical parameters (clinical attachment level)
Time frame: At baseline (single time point)
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 12 Mar 2025.
- Derived from this study: PubMed 42561211Cevik B, Sarioglu A, Kirtiloglu T, Avci B, Tomak L. Association between serum vitamin D3 levels and gingival crevicular fluid osteocalcin and N-terminal telopeptide levels in periodontal health and disease. J Appl Oral Sci. 2026 Aug 3;34:e20260009. doi: 10.1590/1678-7765-2026-0009. eCollection 2026.
- Individual participant dataSharing planned: No. The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.
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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.
Atanur Sarioglu, DDS principal investigator
Ondokuz Mayıs University, Department of Periodontology
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 D Vitamin Deficiency and Osteocalcin, run by Ondokuz Mayıs 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 1 inclusion and 7 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 12 Mar 2025. 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?
Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL) (time frame: At baseline (single time point)). The study lists 4 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 NCT06871631, 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 12 Mar 2025.