Effect of Vitamin D on Periodontal Disease

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04209231
Collaborator
(none)
82
1
5
16.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 1.25(OH)2D3
  • Other: 25(OH)D

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
82 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Principal Investigator
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
chronic periodontitis

Other: 1.25(OH)2D3

Other: 25(OH)D

chronic gingivitis

Other: 1.25(OH)2D3

Other: 25(OH)D

periodontally healthy

Other: 1.25(OH)2D3

Other: 25(OH)D

Outcome Measures

Primary Outcome Measures

  1. periodontal paremeters [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Recep Tayyip Erdoğan University Rize Turkey 53100

Sponsors and Collaborators

  • Recep Tayyip Erdogan University Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hatice Yemenoğlu, Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04209231
Other Study ID Numbers:
  • RecepTayyipErdoganUniversity
First Posted:
Dec 24, 2019
Last Update Posted:
Dec 24, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hatice Yemenoğlu, Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 24, 2019