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

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ClinicalTrials.gov Identifier: NCT03923218
Recruitment Status : Completed
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gülay Tüter, 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

Condition or disease Intervention/treatment
Periodontitis Other: LL-37 levels in Gingival crevicular fluid Other: Serum Vitamin D3 levels Other: Clinical parameters

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : December 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Group/Cohort Intervention/treatment
Smoker patients with chronic periodontitis
Smoker patients with chronic periodontitis
Other: LL-37 levels in Gingival crevicular fluid
Collected gingival crevicular fluid

Other: Serum Vitamin D3 levels
Collected serum

Other: Clinical parameters
Recorded plague index, gingival index, probing depth, clinical attachment level

non-smoker patients with chronic periodontitis
non-smoker patients with chronic periodontitis
Other: LL-37 levels in Gingival crevicular fluid
Collected gingival crevicular fluid

Other: Serum Vitamin D3 levels
Collected serum

Other: Clinical parameters
Recorded plague index, gingival index, probing depth, clinical attachment level

periodontally healthy patients
periodontally healthy patients
Other: LL-37 levels in Gingival crevicular fluid
Collected gingival crevicular fluid

Other: Serum Vitamin D3 levels
Collected serum

Other: Clinical parameters
Recorded plague index, gingival index, probing depth, clinical attachment level




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923218


Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Şeyma BOZKURT DOĞAN, Professor university
Principal Investigator: Elifcan Kıvrak, PhD university
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Responsible Party: Gülay Tüter, Professor, Gazi University
ClinicalTrials.gov Identifier: NCT03923218    
Other Study ID Numbers: 03/2011-27
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülay Tüter, Gazi University:
Gingival crevicular fluid
Vitamin D
LL-37
Serum
periodontitis
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents