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

Completed

• Conditions: D Vitamin Deficiency; Osteocalcin; Gingival Crevicular Fluid

• Registration Number: NCT06871631
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2018-06-10
• Primary Completion: 2022-04-17
• Study Completion: 2025-02-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Corelation between serum vitamin D levels (ng/ml) and osteocalcin (ng/ml) and N-terminal telopeptide levels (nmol/L) in gingival crevicular fluid	At 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.

Trial Locations

Locations (1)

Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University; 🇹🇷 Samsun, Atakum, Turkey