Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Vitamin D Supplementation in Addition to Non-surgical Periodontal Treatment in Individuals With Type II Diabetes Mellitus and Periodontitis

Conditions
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Diabetes Mellitus Type 2 With Periodontal Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D3K2
* Other: Saline Solution


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

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D3K2 with periodontal therapy<br>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). | Dietary Supplement: Vitamin D3K2<br>* 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.<br>|
| Placebo Comparator: Placebo with periodontal therapy<br>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). | Other: Saline Solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Data | HbA1c | At the first 3 and 6th months post treatment for the test and control groups. | 
| Periodontal Clinical Parameters | Probing depth, clinical attachment level | At the 3rd and 6th months post treatment for the test and control groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Data | Serum 25(OH)D3 value | At the 3rd and 6th months post treatment for the test and control groups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Type 2 periodontitis, 25(OH)D3, HbA1c