Vitamin D and Periodontitis

March 16, 2017 updated by: Cankat Kara, T.C. ORDU ÜNİVERSİTESİ

Relationship of Bone Metabolism Biomarkers and Serum 25-Hydroxy Vitamin D in Patients With Chronic Periodontitis

Vitamin D has become important for periodontal disease due to play a role in autoimmunity, bone mineral metabolism and inflammation. Our aim was to investigate the relation between serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood samples were taken from the subjects to assess each patient's periodontal status and for biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α (TNF-α)).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sixty patients (35 girls) who were aged between 25-45 years (30.8 (mean) ± 4.9 (standard deviation) and presented to our faculty for periodontal and other dental problems, participated in the study.

Subjects were divided in to 2 groups each containing 30 patients:

  • Group I - periodontal healthy
  • Group II - untreated chronic periodontitis (radiographic evidence of bone loss and clinical attachment loss in excess of 5 mm in more than six teeth)

Description

  • Inclusion Criteria:

    • never-smokers
    • no history of systemic disease
    • no patients had been under periodontal therapy and medicine for at least 6 months before the study
    • no pregnancy or lactation
    • no alcohol or antioxidant vitamin consumption.

  • Exclusion Criteria:

    • -

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontally healthy subjects
Diagnostic test: fasting venous blood samples
Chronic periodontitis patients
Diagnostic test: fasting venous blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical parameters
Time Frame: Baseline
serum TNF-α
Baseline
Biochemical parameters
Time Frame: Baseline
serum CTx
Baseline
Biochemical parameters
Time Frame: Baseline
serum RANKL
Baseline
Biochemical parameters
Time Frame: Baseline
serum OPG
Baseline
Biochemical parameters
Time Frame: Baseline
serum 25-OH vitamin D
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal parameters
Time Frame: Baseline
The plaque index (PI)
Baseline
Periodontal parameters
Time Frame: Baseline
gingival index (GI)
Baseline
Periodontal parameters
Time Frame: Baseline
probing depth (PD)
Baseline
Periodontal parameters
Time Frame: Baseline
clinical attachment level (CAL)
Baseline

Collaborators and Investigators

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

Sponsor

T.C. ORDU ÜNİVERSİTESİ

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)

June 1, 2015

Primary Completion (Actual)

March 15, 2016

Study Completion (Actual)

April 21, 2016

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrduUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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