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NCT Number: NCT05343273

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University

Erzurum, None Selected, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

taking a blood sample

Diagnostic Test

blood collection for routine biochemical analysis

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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