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

NCT06871631 | Completed

• 1 other identifier: OMU KAEK protokol no: 2017/60
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

D Vitamin Deficiency; Osteocalcin; Gingival Crevicular Fluid

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  At baseline (single time point)

• Periodontal clinical parameters (probing depth)

  At baseline (single time point)

• Periodontal clinical parameters (bleeding on probing)

  At baseline (single time point)

• Periodontal clinical parameters (clinical attachment level)

  At baseline (single time point)

Study Arms (6)

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.

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: One hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Atanur Sarioglu, DDS

  Ondokuz Mayıs University, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 12, 2025
• Study Start: June 10, 2018
• Primary Completion: April 17, 2022
• Study Completion: February 15, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)