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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

Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 22, 2019
Last Update Posted Date April 22, 2019
Actual Study Start Date December 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2019)
  • 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)
  • 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 19, 2019)
  • 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
  • GCF volume [ Time Frame: Baseline ]
    The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Periodontitis
Intervention
  • 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
Study Groups/Cohorts
  • Smoker patients with chronic periodontitis
    Smoker patients with chronic periodontitis
    Interventions:
    • Other: LL-37 levels in Gingival crevicular fluid
    • Other: Serum Vitamin D3 levels
    • Other: Clinical parameters
  • non-smoker patients with chronic periodontitis
    non-smoker patients with chronic periodontitis
    Interventions:
    • Other: LL-37 levels in Gingival crevicular fluid
    • Other: Serum Vitamin D3 levels
    • Other: Clinical parameters
  • periodontally healthy patients
    periodontally healthy patients
    Interventions:
    • Other: LL-37 levels in Gingival crevicular fluid
    • Other: Serum Vitamin D3 levels
    • Other: Clinical parameters
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 19, 2019)
60
Original Actual Enrollment Same as current
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923218
Other Study ID Numbers 03/2011-27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gülay Tüter, Gazi University
Study Sponsor Gazi University
Collaborators Not Provided
Investigators
Principal Investigator: Şeyma BOZKURT DOĞAN, Professor university
Principal Investigator: Elifcan Kıvrak, PhD university
PRS Account Gazi University
Verification Date April 2019