Clinical trial NCT03923218: Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37
Official title: Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: Gingival crevicular fluid
Vitamin D
LL-37
Serum
periodontitis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum D3 Vitamin levels
timeFrame: Baseline
measure: Gingival Crevicular fluid(GCF) LL-37 levels
timeFrame: Baseline
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: Baseline
measure: GCF volume
timeFrame: Baseline
measure: gingival index (GI)
timeFrame: Baseline
measure: Probing depth (PD)
timeFrame: Baseline
measure: Clinical attachment level (CAL)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: university
name: Şeyma BOZKURT DOĞAN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: university
name: Elifcan Kıvrak, PhD
role: PRINCIPAL_INVESTIGATOR
References: