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CompletedNCT03923218Updated Apr 22, 2019

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

An observational study in Periodontitis, sponsored by Gazi University. Completed. Open to participants aged 35 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
35 Years to 50 Years
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Periodontitis

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Keywords

  • Gingival crevicular fluid
  • Vitamin D
  • LL-37
  • Serum
  • periodontitis
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
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.

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

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Smoker patients with chronic periodontitis

    Smoker patients with chronic periodontitis

    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

    Other: LL-37 levels in Gingival crevicular fluid · Other: Serum Vitamin D3 levels · Other: Clinical parameters

  • periodontally healthy patients

    periodontally healthy patients

    Other: LL-37 levels in Gingival crevicular fluid · Other: Serum Vitamin D3 levels · Other: Clinical parameters

Interventions

  • OtherLL-37 levels in Gingival crevicular fluid

    Collected gingival crevicular fluid

  • OtherSerum Vitamin D3 levels

    Collected serum

  • OtherClinical parameters

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

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What researchers measure

Primary outcomes

  1. Serum D3 Vitamin levels

    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)

    Time frame: Baseline

  2. Gingival Crevicular fluid(GCF) LL-37 levels

    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).

    Time frame: Baseline

Secondary outcomes

  1. Plaque index (PI)

    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

    Time frame: Baseline

  2. GCF volume

    The GCF volume was notably higher in both CP groups than in CTRL group (p\<0.001).

    Time frame: Baseline

  3. gingival index (GI)

    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).

    Time frame: Baseline

  4. Probing depth (PD)

    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).

    Time frame: Baseline

  5. Clinical attachment level (CAL)

    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).

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03923218
Lead sponsor
Gazi University
Responsible party
Gülay Tüter (Professor, Gazi University) — Principal investigator
First posted
Apr 22, 2019
Start date
Dec 2011
Primary completion
Jul 2012
Completion
Jul 2015
Last update
Apr 22, 2019

Study contacts

Şeyma BOZKURT DOĞAN, Professor
principal investigator · university
Elifcan Kıvrak, PhD
principal investigator · university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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