Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2 With Periodontal Disease
• Interventions: Other: Saline Solution; Dietary Supplement: Vitamin D3K2

• Registration Number: NCT06077708
• Lead Sponsor: Kırıkkale University

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).

Study Timeline

• Study Start: 2022-08-23
• Primary Completion: 2022-09-30
• Study Completion: 2023-02-28
• Status Verified: 2023-10
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo with periodontal therapy	Saline Solution	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).
D3K2 with periodontal therapy	Vitamin D3K2	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).

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Kirikkale University; 🇹🇷 Kırıkkale, Turkey