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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343273
• Other study ID #: 9099
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: May 10, 2022

Study information

• Verified date: June 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 10, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• taking a blood sample
blood collection for routine biochemical analysis

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Dental Plaque	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