Skip to main content
OpenTrials
Completed

NCT Number: NCT03923218

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

LL-37 levels in Gingival crevicular fluid

Other

Collected gingival crevicular fluid

Serum Vitamin D3 levels

Other

Collected serum

Clinical parameters

Other

Recorded plague index, gingival index, probing depth, clinical attachment level

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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

  2. GCF volume

    Time frame: Baseline

    The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).

  3. 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).

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Apr 22, 2019
Registry last updated
Apr 22, 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.

Published trials that share one or more normalized conditions with this study.