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

19 de abril de 2019 actualizado por: Gülay Tüter, Gazi University

Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis

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

Descripción general del estudio

Descripción detallada

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 de estudio

De observación

Inscripción (Actual)

60

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años a 50 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum D3 Vitamin levels
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plaque index (PI)
Periodo de tiempo: 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
Periodo de tiempo: Baseline
The GCF volume was notably higher in both CP groups than in CTRL group (p<0.001).
Baseline
gingival index (GI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Şeyma BOZKURT DOĞAN, Professor, University
  • Investigador principal: Elifcan Kıvrak, PhD, University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2011

Finalización primaria (Actual)

1 de julio de 2012

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

17 de abril de 2019

Primero enviado que cumplió con los criterios de control de calidad

19 de abril de 2019

Publicado por primera vez (Actual)

22 de abril de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

19 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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