Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

Sponsor

Kırıkkale University (Other)

Overall Status

Completed

CT.gov ID

NCT06077708

Collaborator

(none)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 With Periodontal Disease	Dietary Supplement: Vitamin D3K2 Other: Saline Solution	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 23, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Dietary Supplement: 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 Comparator: 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).	Other: 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.

Arm

Intervention/Treatment

Active Comparator: 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).

Dietary Supplement: 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 Comparator: 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).

Other: 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.

Outcome Measures

Primary Outcome Measures

Biochemical Data [At the first 3 and 6th months post treatment for the test and control groups.]
HbA1c
Periodontal Clinical Parameters [At the 3rd and 6th months post treatment for the test and control groups.]
Probing depth, clinical attachment level

Secondary Outcome Measures

Biochemical Data [At the 3rd and 6th months post treatment for the test and control groups.]
Serum 25(OH)D3 value

Eligibility Criteria

Criteria

Ages Eligible for Study:

39 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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