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

NCT05343273 | Completed

• 1 other identifier: 9099
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency; Periodontitis

Keywords

Total 25(OH)D; Bioavailable 25(OH)D; Free 25(OH)D; Periodontitis

Outcome Measures

Primary Outcomes (5)

• Measurements of 25(OH)D

  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

  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

  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

  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

  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 Outcomes (1)

• Dental Plaque

  Day 1

Study Arms (2)

Healthy

Diagnostic Test: taking a blood sample

Periodontitis

Diagnostic Test: taking a blood sample

Interventions

taking a blood sample DIAGNOSTIC_TEST

blood collection for routine biochemical analysis

Healthy; Periodontitis

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Without systemic disease,
• Had a least 14 teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, None Selected, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Aydin T, Dilsiz A, Eminoglu DO, Sahin AB, Laloglu E, Bayrakdar YE. Total, free, and bioavailable 25-hydroxyvitamin D levels in patients with periodontitis (stage III): a case-control study. Clin Oral Investig. 2023 Jan;27(1):421-430. doi: 10.1007/s00784-022-04844-9. Epub 2023 Jan 4.

  PMID: 36598602 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Periodontitis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 25, 2022
• Study Start: March 10, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 10, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

TU (1)