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Serum Vitamin D and Gingival Crevicular Fluid Levels of Osteocalcin and N-Terminal Telopeptide

Relationships Between Serum Vitamin D Levels and Osteocalcin and N-terminal Telopeptide Levels in Gingival Crevicular Fluid

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06871631
Enrollment
120
Registered
2025-03-12
Start date
2018-06-10
Completion date
2025-02-15
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D Vitamin Deficiency, Gingival Crevicular Fluid, Osteocalcin

Keywords

Vitamin D, Osteocalcin, N-Terminal Telopeptide, Gingival Crevicular Fluid

Brief 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. 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.

Interventions

None listed

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
25 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Total N-Terminal Telopeptide Levels in Gingival Crevicular Fluid (nmol/L)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.
Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)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)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)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.

Secondary

MeasureTime frameDescription
Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluidAt baseline (single time point)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.
Periodontal clinical parameters (probing depth)At baseline (single time point)Probing depth of ≤3 mm was recorded as within the normal healthy range, while ≥5 mm was considered unhealthy
Periodontal clinical parameters (bleeding on probing)At baseline (single time point)Bleeding on probing (BoP) \<10% was considered within the healthy range, while ≥10% was classified as unhealthy.
Periodontal clinical parameters (clinical attachment level)At baseline (single time point)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026