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NCT Number: NCT06077708

Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

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.

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Key information

Conditions

Diabetes Mellitus Type 2 With Periodontal Disease Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

39 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirikkale University

Kirikkale, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3K2

Dietary Supplement

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.

Saline solution

Other

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 outcomes

  1. Biochemical Data

    Time frame: At the first 3 and 6th months post treatment for the test and control groups.

    HbA1c

  2. Periodontal Clinical Parameters

    Time frame: At the 3rd and 6th months post treatment for the test and control groups.

    Probing depth, clinical attachment level

Secondary outcomes

  1. Biochemical Data

    Time frame: At the 3rd and 6th months post treatment for the test and control groups.

    Serum 25(OH)D3 value

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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