Clinical trial NCT06871631: Serum Vitamin D and Gingival Crevicular Fluid Levels of Osteocalcin and N-Terminal Telopeptide
Official title: Relationships Between Serum Vitamin D Levels and Osteocalcin and N-terminal Telopeptide Levels in Gingival Crevicular Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: D Vitamin Deficiency
Osteocalcin
Gingival Crevicular Fluid
Keywords: Vitamin D
Osteocalcin
N-Terminal Telopeptide
Gingival Crevicular Fluid
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 120
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Osteocalcin Concentration in Gingival Crevicular Fluid (ng/mL)
timeFrame: At baseline (single time point)
measure: N-Terminal Telopeptide Concentration in Gingival Crevicular Fluid (nmol/L)
timeFrame: At baseline (single time point)
measure: Total Osteocalcin Levels in Gingival Crevicular Fluid (ng/ml)
timeFrame: At baseline (single time point)
measure: Total N-Terminal Telopeptide Levels in Gingival Crevicular Fluid (nmol/L)
timeFrame: At baseline (single time point)
Secondary outcomes:
measure: Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluid
timeFrame: At baseline (single time point)
measure: Periodontal clinical parameters (probing depth)
timeFrame: At baseline (single time point)
measure: Periodontal clinical parameters (bleeding on probing)
timeFrame: At baseline (single time point)
measure: Periodontal clinical parameters (clinical attachment level)
timeFrame: At baseline (single time point)
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University, Department of Periodontology
name: Atanur Sarioglu, DDS
role: PRINCIPAL_INVESTIGATOR
References: