Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37

April 19, 2019 updated by: Gülay Tüter, Gazi University

Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis

The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers

Study Overview

Detailed Description

Background: Cathelicidin LL-37, an antimicrobial peptide, is part of the host innate immune response in the oral cavity. The aims of this study are to evaluate; gingival crevicular fluid (GCF) levels of LL-37, serum vitamin D3 levels and periodontal clinical recordings in smoker and nonsmoker patients with chronic periodontitis (CP).

Methods:

This study consisted a total of 60 volunteers including 20 smoker patients with CP (CP-1 group), 20 non-smoker patients with CP (CP-2 group) and 20 periodontally healthy subjects (CTRL group). Prior to participation, the design and purpose of the research were explained to each subjects, and written informed consent form was obtained from 60 individuals before the study.

The periodontal status of the patients were determined by measuring the probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) All clinical parameters were measured on six sites per tooth from the full-mouth teeth (mesiobuccal, distobuccal,midbuccal, mesiolingual, distolingual and midlingual) using a William's periodontal probe calibrated in millimeters by the same examiner. All samples were obtained on the day following clinical examinations of the individuals. The deepest six pockets site per individual were chosen for collection of GCF across both of the periodontitis groups. Six pocket locations showing a lack of clinical inflammation were also tested to guarantee collection of a sufficient volume of GCF across the CTRL groups.

GCF levels of LL-37 were measured by ELISA and serum levels of vitamin D3 were analysed by High-performance liquid chromatography (HPLC). Statistical analysis were performed.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The volunteers participitating in the study were choosen from among individuals scheduled to undergo either dental treatment or dental check at the Deparment of Perioodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey.

Description

Inclusion Criteria for chronic periodontitis groups:

  • Clinical attachment loss ≥ 5mm
  • Probing depth ≥5mm
  • Bone loss affecting >30% of the existing teeth on clinical and radiographic examination
  • gingival index (GI) score> 1

Inclusion criteria for control group:

  • full-mouth PD was≤ 3mm,
  • Gingival index <1
  • there was no indication of Attachment Loss or no radiographic evidence of alveolar bone loss in control group.
  • Non-smokers.

Smoking criteria for groups:

  • patients smoked more than 10 cigarettes in a day
  • smoking for 3 or more years,

Exclusion Criteria:

  • systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)
  • pregnancy, lactation or menopause term,
  • antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,
  • non-surgical periodontal treatment during the last 6 months before the study,
  • treatment with Vitamin D supplementation before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smoker patients with chronic periodontitis
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level
non-smoker patients with chronic periodontitis
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level
periodontally healthy patients
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum D3 Vitamin levels
Time Frame: Baseline
The plasma levels of vitamin D3 were greater in the CP-2 group than in the CP-1 group. But, no statistically significant difference was determined between the CP groups (P>0.05)
Baseline
Gingival Crevicular fluid(GCF) LL-37 levels
Time Frame: Baseline
The concentration of LL-37 in GCF was significantly higher in both of the CP groups than in the CTRL group (p<0.001). Although GCF LL-37 concentration levels were greater in the CP-1 group than in the CP-2 group, the difference did not reach the statistical significance between the CP groups (p>0.05).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (PI)
Time Frame: Baseline

The full-mouth and sample sites PI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).

were measured on six sites per tooth from the full-mouth teeth

Baseline
GCF volume
Time Frame: Baseline
The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).
Baseline
gingival index (GI)
Time Frame: Baseline
The full-mouth and sample sites GI recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Baseline
Probing depth (PD)
Time Frame: Baseline
The full-mouth and sample sites PD recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Baseline
Clinical attachment level (CAL)
Time Frame: Baseline
The full-mouth and sample sites CAL recordings were significantly higher in both CP groups (CP-1 and CP-2) than in the CTRL group (p<0.001).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Şeyma BOZKURT DOĞAN, Professor, University
  • Principal Investigator: Elifcan Kıvrak, PhD, University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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