Effect of Vitamin D on Periodontal Disease

Completed

• Conditions: Vitamin D Deficiency; Periodontal Diseases
• Interventions: Other: 1.25(OH)2D3; Other: 25(OH)D

• Registration Number: NCT04209231
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

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.

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2019-12
• Study First Submitted: 2019-12-07
• Study First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Study First Posted: 2019-12-24
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic gingivitis	25(OH)D	-
periodontally healthy	25(OH)D	-
chronic periodontitis	1.25(OH)2D3	-
chronic periodontitis	25(OH)D	-
periodontally healthy	1.25(OH)2D3	-
chronic gingivitis	1.25(OH)2D3	-

Primary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Recep Tayyip Erdoğan University; 🇹🇷 Rize, Turkey