Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

Kırıkkale University38 enrolled

Overview

This study investigates the clinical and biochemical results of vitamin D supplementation in addition to non-surgical periodontal treatment in individuals with Type II diabetes mellitus and periodontitis.

38 individuals with T2DM and periodontitis were included into the study. Clinical periodontal measurements including probing depth, clinical attachment level, plaque and gingival indices were recorded The individuals included in the study were divided into two groups: Individuals given D3K2 with periodontal therapy were included in the test group, and individuals given placebo with periodontal therapy were included in the control group. All serum and gingival crevicular fluid samples from individuals who underwent non-surgical periodontal treatment were taken again at 3rd and 6th months, and clinical periodontal measurements were recorded. Glycated hemoglobin A1c (HbA1c), fasting blood glucose (FBG), 25(OH)D3, parathyroid hormone (PTH), calcium (Ca) and magnesium (Mg) values were determined in serum samples. GCF and serum IL-1ß and IL-10 values were analyzed by enzyme-linked immunosorbent analysis (ELISA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 2 With Periodontal Disease

Interventions

Vitamin D3K2DIETARY_SUPPLEMENT

Non-surgical periodontal treatment was applied to all individuals included in the study. 2 drops of the preparation containing 25 µg D3 \[1000 IU\] and 11.25 µg K2 in each drop were given per day to participants in the test group.

Saline SolutionOTHER

Non-surgical periodontal treatment was applied to all individuals included in the study and saline solution (0.9% NaCl) was given as placebo, 2 drops per day to particiapants in the control group.

Eligibility

Sex: ALLMin age: 39 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals with Stage I-II periodontitis 2. Individuals with HbA1c value ≥6.5 and diagnosed with type 2 DM according to ADA at least 1 year before the study 3. Individuals who do not have a systemic disease other than DM 4. Individuals who do not have systemic complications of diabetes 5. Individuals with 25(OH)D3 value between 20 ng/mL and 30 ng/mL 6. Individuals who are under the control of a doctor for their diabetes 7. Individuals who have not used any antibiotics or long-term anti-inflammatory drugs in the last 6 months 8. Individuals who have not received periodontal treatment in the last 6 months 9. Individuals with BMI value of 18.5 to 30 kg/m2 Exclusion Criteria: 1. Smokers 2. Individuals who use alcohol 3. Pregnant or lactating individuals 4. Individuals taking any antioxidant or vitamin supplements

Locations (1)

Kirikkale University

Kırıkkale, Turkey (Türkiye)

Outcomes

Primary Outcomes

Biochemical Data

HbA1c

Time frame: At the first 3 and 6th months post treatment for the test and control groups.

Periodontal Clinical Parameters

Probing depth, clinical attachment level

Time frame: At the 3rd and 6th months post treatment for the test and control groups.

Secondary Outcomes

Biochemical Data

Serum 25(OH)D3 value

Time frame: At the 3rd and 6th months post treatment for the test and control groups.

Data from ClinicalTrials.gov

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