NCT06077708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 5, 2023

Last Update Submit

October 5, 2023

Conditions

Diabetes Mellitus Type 2 With Periodontal Disease

Keywords

PeriodontitisType 2 periodontitis25(OH)D3HbA1c

Outcome Measures

Primary Outcomes (2)

  • Biochemical Data

    HbA1c

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

  • Periodontal Clinical Parameters

    Probing depth, clinical attachment level

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

Secondary Outcomes (1)

  • Biochemical Data

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

Study Arms (2)

D3K2 with periodontal therapy

ACTIVE COMPARATOR

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

Placebo with periodontal therapy

PLACEBO COMPARATOR

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

Interventions

Vitamin D3K2DIETARY_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.

D3K2 with periodontal therapy
Saline SolutionOTHER

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.

Placebo with periodontal therapy

Eligibility Criteria

Age39 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smokers
  • Individuals who use alcohol
  • Pregnant or lactating individuals
  • Individuals taking any antioxidant or vitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirikkale University

Kırıkkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

August 23, 2022

Primary Completion

September 30, 2022

Study Completion

February 28, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)