25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III)

June 1, 2022 updated by: Tugba Aydin, Ataturk University

Total, Free, and Bioavailable 25-Hydroxyvitamin D Levels in Patients With Periodontitis (Stage III): A Case-Control Study

Periodontitis; is an inflammatory disease of tissues characterized by bone destruction around the teeth. Vitamin D plays an important role in several inflammatory diseases by promoting the expression of inflammatory cytokines such as interleukin IL-1, IL-6, and IL-1β, which are directly related to periodontal attachment loss and bone demineralization. These facts suggest that vitamin D may be associated with periodontal disease. Many studies have been conducted on the relationships between serum 25-hydroxyvitamin D (25(OH)D) levels, periodontal disease, and tooth loss. However, as far as we know, there is no study on the relationship between periodontitis and free and bioavailable 25 (OH) vitamin D. In our study, over the age of 35; two groups will be formed, consisting of 40 healthy and 40 periodontitis individuals. Serum total 25 (OH) D level and vitamin D binding protein level will be analyzed by ELISA method, and bioavailable 25 (OH) D level will be calculated using total 25 (OH) D and vitamin D binding protein levels. The aim of this study; To evaluate the total, free and bioavailable 25 (OH) vitamin D levels of patients with periodontitis by comparing them with healthy controls, and to investigate whether bioavailable 25 (OH) D plays a role in the pathogenesis of periodontitis or can be a simple marker of disease activity in the light of these findings.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • None Selected
      • Erzurum, None Selected, Turkey, 25240
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Forty patients with stage 3 periodontitis and 40 healthy volunteers were included in this case-control study at Atatürk University, Department of Dentistry, Department of Periodontology.

Description

Inclusion Criteria:

  • Without systemic disease,
  • Had a least 14 teeth

Exclusion Criteria:

  • Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months,
  • Individuals with an allergy to any ingredient used in the study,
  • Smokers,
  • Pregnant or breastfeeding women,
  • Using vitamin D,
  • Individuals diagnosed with obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
blood collection for routine biochemical analysis
Periodontitis
blood collection for routine biochemical analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.
Total 25(OH)D levels in serum samples will be measured by ELISA method, using the "Human 25-Dihydroxy vitamin D ELISA Kit" (BT LAB, Cat No: E1981Hu, China) in accordance with the manufacturer's instructions. Results will be recorded in ng/mL.
Within one week of collecting blood samples from all participants.
Measurements of VDBP
Time Frame: Within one week of collecting blood samples from all participants.
VDBP levels in serum samples will be studied by ELISA (Enzyme Linked Immunosorbend Assay) method using Elabscience brand kit (Elabscience Biotechnology Co., Ltd). Results will be recorded in (ug/mL.
Within one week of collecting blood samples from all participants.
Measurements of Albumin
Time Frame: Within one week of collecting blood samples from all participants.
Serum albumin levels (g/dL) will be measured on the Roche Cobas c702 instrument (Germany) using commercial kits.
Within one week of collecting blood samples from all participants.
Calculation of Bioavailable 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.

It will be calculated using calculations using affinity constants and calculated free 25(OH)D and measured albumin levels.

Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1

Bioavailable 25(OH)D concentration = (6 x 10^5 x [Albumin]+1) x calculated free 25(OH)D

Results will be recorded in ng/mL.

Within one week of collecting blood samples from all participants.
Calculation of Bioavailable Free 25(OH)D
Time Frame: Within one week of collecting blood samples from all participants.

It will be calculated using calculations using affinity constants and measured total serum 25(OH)D, VDBP and albumin levels.

Kalb = affinity constant between vitamin D and albumin = 6 x 10^5 M^-1 KVDBP = affinity constant between vitamin D and VDBP = 7 x 10^8 M^-1 [Albumin] = serum albumin concentration = (serum albumin g/L) / 66.430 g/mol [VDBP] = serum vitamin D binding protein concentration = (serum VDBP g/L) / 58.000 g/mol

Free 25(OH)D concentration = Total 25(OH)D / 1+(6 x 10^5 x [Albumin]) + (7 x 10^8 x [VDBP])

Results will be recorded in pg/mL.

Within one week of collecting blood samples from all participants.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Plaque
Time Frame: Day 1

Plaque scores recorded by using the Silness&Löe Plaque Index

PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically.

PI 3: Heavy plaque accumulation is detected at the gin- gival margin and in the interdental spaces.

Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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