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Vitamin D and Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088488
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Cankat Kara, T.C. ORDU ÜNİVERSİTESİ

Brief Summary:
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)).

Condition or disease Intervention/treatment
Alveolar Bone Loss Diagnostic Test: fasting venous blood samples

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Relationship of Bone Metabolism Biomarkers and Serum 25-Hydroxy Vitamin D in Patients With Chronic Periodontitis
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : April 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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



Primary Outcome Measures :
  1. Biochemical parameters [ Time Frame: Baseline ]
    serum TNF-α

  2. Biochemical parameters [ Time Frame: Baseline ]
    serum CTx

  3. Biochemical parameters [ Time Frame: Baseline ]
    serum RANKL

  4. Biochemical parameters [ Time Frame: Baseline ]
    serum OPG

  5. Biochemical parameters [ Time Frame: Baseline ]
    serum 25-OH vitamin D


Secondary Outcome Measures :
  1. Periodontal parameters [ Time Frame: Baseline ]
    The plaque index (PI)

  2. Periodontal parameters [ Time Frame: Baseline ]
    gingival index (GI)

  3. Periodontal parameters [ Time Frame: Baseline ]
    probing depth (PD)

  4. Periodontal parameters [ Time Frame: Baseline ]
    clinical attachment level (CAL)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria
  • 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:

    • -
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Responsible Party: Cankat Kara, Professor, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT03088488    
Other Study ID Numbers: OrduUniversity
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cankat Kara, T.C. ORDU ÜNİVERSİTESİ:
25-OH vitamin D
RANKL
Osteoprotogerin
TNF-α
Additional relevant MeSH terms:
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Alveolar Bone Loss
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy