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Completed

NCT Number: NCT04209231

Effect of Vitamin D on Periodontal Disease

Background. Vitamin D has both direct effects on bone metabolism and an antimicrobial effect on periodontopathogens. It also inhibits inflammatory mediators that contribute to periodontal destruction. The purpose of this study was to evaluate the association between serum 1.25-hydroxyvitamin D (1.25(OH)2D3) and 25(OH)D levels and periodontal inflammation.

Methods. This study included 28 subjects with chronic gingivitis, 29 subjects with chronic periodontitis and 25 periodontally healthy subjects. Blood samples were collected from the participants to determine serum levels of 25(OH)D, 1.25(OH)2D3, tumour necrosis factor α (TNF-α), C-reactive protein (CRP) and interleukin 6 (IL-6). Clinical parameters were recorded. Results were statistically analysed with a Shapiro-Wilk's test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test and post-hoc multiple comparison test.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Gingival Diseases Gingivitis Infections Malnutrition Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University

Rize, 53100, Turkey (Türkiye)

About this study

The subjects included in the study were selected from among patients who applied to our clinic, for routine periodontal examinations. Individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases were excluded from the study. In addition, since the region's level of sunlight exposure may have an effect on the level of vitamin D, participants were required to live in the region for the last five years.

A total of 82 subjects, including 25 as a periodontally healthy control group, 28 with chronic gingivitis and 29 with chronic periodontitis, were included in the study. Clinical criteria for chronic periodontitis are the formation of plaque and calculus and ≥ 5 milimeter (mm) pocket depth or attachment loss in more than 30% of the teeth. Diagnosis criteria for chronic gingivitis are the formation of plaque and/or calculus in the mouth, bleeding, and no loss of pocket or attachment. The diagnosis criteria for periodontally healthy individuals are having clinically healthy periodontal tissues or minimal periodontal inflammation, with no loss of pocket or attachment.

Who can participate

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

Inclusion criteria

  • live in the region for the last five years.

Exclusion criteria

  • individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases.

Treatment and study plan

1.25(OH)2D3

Other

25(OH)D

Other

Primary outcomes

  1. periodontal paremeters

    Time frame: December 2015- March 2016

    Attachment loss and pocket depth were measured from the six surfaces of the teeth (buccal, palatal/lingual, mesiobuccal, mesiolingual, distobuccal and distolingual) except for the third molars. These values were calculated in millimeters (mm).

  2. laboratory analysis

    Time frame: December 2015- March 2016

    Venous blood samples were collected from the patients on the examination day that were allowed to rest for half an hour and then centrifuged at 4000 rpm for 10 min. Serum samples were separated into Eppendorf tubes and stored at -20°C until the experiment day. On the day of biochemical analysis, serum samples were thawed at room temperature and studied according to the manufacturer's instructions. TNF-a, 1,25(OH)2D3, IL-6 were calculated in pg/mL, 25(OH)D was calculated ng/mL and CRP was calculated mg/dL.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2019
Registry last updated
Dec 24, 2019

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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