NCT04209231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 7, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

periodontitisgingivitisvitamin D

Outcome Measures

Primary Outcomes (2)

  • periodontal paremeters

    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).

    December 2015- March 2016

  • laboratory analysis

    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.

    December 2015- March 2016

Study Arms (3)

chronic periodontitis

Other: 1.25(OH)2D3Other: 25(OH)D

chronic gingivitis

Other: 1.25(OH)2D3Other: 25(OH)D

periodontally healthy

Other: 1.25(OH)2D3Other: 25(OH)D

Interventions

chronic gingivitischronic periodontitisperiodontally healthy
25(OH)DOTHER
chronic gingivitischronic periodontitisperiodontally healthy

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

live in the region for the last five years.

You may qualify if:

  • live in the region for the last five years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D DeficiencyPeriodontal DiseasesPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 24, 2019

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations