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Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

Primary Purpose

Diabetes Mellitus Type 2 With Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D3K2
Saline Solution
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 With Periodontal Disease focused on measuring Periodontitis, Type 2 periodontitis, 25(OH)D3, HbA1c

Eligibility Criteria

39 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kirikkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

D3K2 with periodontal therapy

Placebo with periodontal therapy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Biochemical Data
HbA1c
Periodontal Clinical Parameters
Probing depth, clinical attachment level

Secondary Outcome Measures

Biochemical Data
Serum 25(OH)D3 value

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT06077708
Brief Title
Diabetes Mellitus and Periodontitis and Vitamin D Supplementation
Official Title
Effect of Vitamin D Supplementation in Addition to Non-surgical Periodontal Treatment in Individuals With Type II Diabetes Mellitus and Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 With Periodontal Disease
Keywords
Periodontitis, Type 2 periodontitis, 25(OH)D3, HbA1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D3K2 with periodontal therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo with periodontal therapy
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3K2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biochemical Data
Description
HbA1c
Time Frame
At the first 3 and 6th months post treatment for the test and control groups.
Title
Periodontal Clinical Parameters
Description
Probing depth, clinical attachment level
Time Frame
At the 3rd and 6th months post treatment for the test and control groups.
Secondary Outcome Measure Information:
Title
Biochemical Data
Description
Serum 25(OH)D3 value
Time Frame
At the 3rd and 6th months post treatment for the test and control groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Kirikkale University
City
Kırıkkale
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

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