- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03923218
Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37
Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Smoker patients with chronic periodontitis
|
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level
|
non-smoker patients with chronic periodontitis
|
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level
|
periodontally healthy patients
|
Collected gingival crevicular fluid
Collected serum
Recorded plague index, gingival index, probing depth, clinical attachment level
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serum D3 Vitamin levels
Lasso di tempo: 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)
|
Baseline
|
Gingival Crevicular fluid(GCF) LL-37 levels
Lasso di tempo: 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).
|
Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Plaque index (PI)
Lasso di tempo: 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 |
Baseline
|
GCF volume
Lasso di tempo: Baseline
|
The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).
|
Baseline
|
gingival index (GI)
Lasso di tempo: 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).
|
Baseline
|
Probing depth (PD)
Lasso di tempo: 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).
|
Baseline
|
Clinical attachment level (CAL)
Lasso di tempo: 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).
|
Baseline
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Şeyma BOZKURT DOĞAN, Professor, University
- Investigatore principale: Elifcan Kıvrak, PhD, University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 03/2011-27
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