Diabetes Mellitus and Periodontitis and Vitamin D Supplementation
NCT ID: NCT06077708
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2022-08-23
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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D3K2 with periodontal therapy
Individuals given D3K2 with periodontal therapy were included in the test 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).
Vitamin D3K2
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.
Placebo with periodontal therapy
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).
Saline Solution
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.
Interventions
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Vitamin D3K2
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 Solution
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 Criteria
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Inclusion Criteria
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
2. Individuals who use alcohol
3. Pregnant or lactating individuals
4. Individuals taking any antioxidant or vitamin supplements
39 Years
70 Years
ALL
Yes
Sponsors
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Kırıkkale University
OTHER
Responsible Party
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Meltem Karsiyaka Hendek
Assoc. Prof.
Locations
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Kirikkale University
Kırıkkale, , Turkey (Türkiye)
Countries
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Other Identifiers
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2022/040
Identifier Type: -
Identifier Source: org_study_id
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