- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿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
Patrocinador
Investigadores
- Investigador principal: Şeyma BOZKURT DOĞAN, Professor, University
- Investigador principal: Elifcan Kıvrak, PhD, University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 03/2011-27
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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