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

Completed

• Conditions: Periodontitis
• Interventions: Other: LL-37 levels in Gingival crevicular fluid; Other: Serum Vitamin D3 levels; Other: Clinical parameters

• Registration Number: NCT03923218
• Lead Sponsor: Gazi University

Brief Summary

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

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-07
• Study Completion: 2015-07
• Status Verified: 2019-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smoker patients with chronic periodontitis	LL-37 levels in Gingival crevicular fluid	Smoker patients with chronic periodontitis
Smoker patients with chronic periodontitis	Clinical parameters	Smoker patients with chronic periodontitis
non-smoker patients with chronic periodontitis	Serum Vitamin D3 levels	non-smoker patients with chronic periodontitis
periodontally healthy patients	LL-37 levels in Gingival crevicular fluid	periodontally healthy patients
periodontally healthy patients	Serum Vitamin D3 levels	periodontally healthy patients
Smoker patients with chronic periodontitis	Serum Vitamin D3 levels	Smoker patients with chronic periodontitis
non-smoker patients with chronic periodontitis	LL-37 levels in Gingival crevicular fluid	non-smoker patients with chronic periodontitis
non-smoker patients with chronic periodontitis	Clinical parameters	non-smoker patients with chronic periodontitis
periodontally healthy patients	Clinical parameters	periodontally healthy patients

Primary Outcome Measures

Name	Time	Method
Gingival Crevicular fluid(GCF) LL-37 levels	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).
Serum D3 Vitamin levels	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)

Secondary Outcome Measures

Name	Time	Method
Plaque index (PI)	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
Probing depth (PD)	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).
GCF volume	Baseline	The GCF volume was notably higher in both CP groups than in CTRL group (p\<0.001).
Clinical attachment level (CAL)	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).
gingival index (GI)	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).