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

  • Clinicaltrials.gov identifier

    NCT03923218

  • Recruitment Status

    Completed

  • First Posted

    April 22, 2019

  • Last update posted

    April 22, 2019

Study Description

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:Periodontitis
  • Intervention/Treatment: Other: LL-37 levels in Gingival crevicular fluid
    Other: Serum Vitamin D3 levels
    Other: Clinical parameters
  • Phase: N/A

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 Design

  • 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

Groups and Cohorts

Groups/Cohorts 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

Outcome Measures

  • 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. 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).
  • 2. 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).
  • 3. 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).
  • 4. 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
  • 5. GCF volume [ Time Frame: Baseline ]
    The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).

Eligibility Criteria

  • Ages Eligible for Study: 35 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

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Gazi University

Investigators

Principal Investigator: Şeyma BOZKURT DOĞAN, Professor university

Principal Investigator: Elifcan Kıvrak, PhD university

More Information

  • Responsible Party: Gazi University
  • ClinicalTrials.gov Identifier: NCT03923218 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Gazi University: LL-37
    Gingival crevicular fluid
    Vitamin D
    Serum
    periodontitis
  • Additional relevant MeSH terms: Periodontitis