Diabetes Mellitus and Periodontitis and Vitamin D Supplementation

October 5, 2023 updated by: Meltem Karsiyaka Hendek, Kırıkkale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kırıkkale, Turkey
        • Kirikkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Data
Time Frame: At the first 3 and 6th months post treatment for the test and control groups.
HbA1c
At the first 3 and 6th months post treatment for the test and control groups.
Periodontal Clinical Parameters
Time Frame: At the 3rd and 6th months post treatment for the test and control groups.
Probing depth, clinical attachment level
At the 3rd and 6th months post treatment for the test and control groups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Data
Time Frame: At the 3rd and 6th months post treatment for the test and control groups.
Serum 25(OH)D3 value
At the 3rd and 6th months post treatment for the test and control groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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