Clinical trial NCT06077708: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 With Periodontal Disease
Keywords: Periodontitis
Type 2 periodontitis
25(OH)D3
HbA1c
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 38
Sex: ALL
Minimum age (years): 39
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical Data
timeFrame: At the first 3 and 6th months post treatment for the test and control groups.
measure: Periodontal Clinical Parameters
timeFrame: At the 3rd and 6th months post treatment for the test and control groups.
Secondary outcomes:
measure: Biochemical Data
timeFrame: At the 3rd and 6th months post treatment for the test and control groups.
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kirikkale University
Study officials:
References: