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

NCT ID: NCT03923218

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Periodontitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Smoker patients with chronic periodontitis

Smoker patients with chronic periodontitis

LL-37 levels in Gingival crevicular fluid

Intervention Type: OTHER

Collected gingival crevicular fluid

Serum Vitamin D3 levels

Intervention Type: OTHER

Collected serum

Clinical parameters

Intervention Type: OTHER

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

non-smoker patients with chronic periodontitis

non-smoker patients with chronic periodontitis

LL-37 levels in Gingival crevicular fluid

Intervention Type: OTHER

Collected gingival crevicular fluid

Serum Vitamin D3 levels

Intervention Type: OTHER

Collected serum

Clinical parameters

Intervention Type: OTHER

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

periodontally healthy patients

periodontally healthy patients

LL-37 levels in Gingival crevicular fluid

Intervention Type: OTHER

Collected gingival crevicular fluid

Serum Vitamin D3 levels

Intervention Type: OTHER

Collected serum

Clinical parameters

Intervention Type: OTHER

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

Interventions

LL-37 levels in Gingival crevicular fluid

Collected gingival crevicular fluid

Intervention Type: OTHER

Serum Vitamin D3 levels

Collected serum

Intervention Type: OTHER

Clinical parameters

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Gülay Tüter

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şeyma BOZKURT DOĞAN, Professor

Role: PRINCIPAL_INVESTIGATOR

university

Elifcan Kıvrak, PhD

Role: PRINCIPAL_INVESTIGATOR

university

Other Identifiers

03/2011-27

Identifier Type: -

Identifier Source: org_study_id