- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07607639
Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis
Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis
This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels.
Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity.
This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. Approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to pubertal hormonal variability that may affect inflammatory biomarker levels.
Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA.
The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aycan Dal Dönertaş
- Número de teléfono: +903382252595
- Correo electrónico: aycandal@outlook.com
Copia de seguridad de contactos de estudio
- Nombre: Selcen Özcan Bulut
- Correo electrónico: selcen_ozcan@hotmail.com
Ubicaciones de estudio
-
-
-
Niğde, Turquía (Türkiye), 51240
- Reclutamiento
- Niğde Ömer Halisdemir University Faculty of Dentistry
-
Contacto:
- Merdan Doğan
- Número de teléfono: 905422076565
- Correo electrónico: merdan@ohu.edu.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Individuals aged 8-12 years (child group) or 15-24 years (young adult group)
- Clinical diagnosis of gingivitis
- Presence of fully erupted tooth #31 with closed apex
- Systemically healthy individuals
- No history of periodontal treatment in the last 3 months
- No antibiotic or anti-inflammatory drug use in the last 3 months
- Good cooperation and willingness to participate
- Written informed consent from participants or legal guardians (for minors)
Exclusion Criteria:
- Age 13-14 years (transitional pubertal period)
- Presence of periodontitis or other periodontal diseases
- Systemic, genetic, or immunological diseases
- Acute oral infections or conditions requiring emergency treatment
- Orthodontic appliances in the sampling region
- Smokers
- Pregnant or lactating individuals
- Individuals with cognitive, psychological, or physical disabilities affecting cooperation
- Inadequate eruption or incomplete root development of tooth #31
- Refusal to participate or withdrawal of consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Childhood gingivitis group
Systemically healthy children aged 8-12 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
|
Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
|
Young adult gingivitis group
Systemically healthy young adults aged 15-24 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
|
Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Gingival crevicular fluid TNF-α levels
Periodo de tiempo: Baseline
|
Baseline
|
|
Gingival crevicular fluid IL-1β levels
Periodo de tiempo: Baseline
|
Baseline
|
|
Gingival crevicular fluid IL-10 levels
Periodo de tiempo: Baseline
|
Baseline
|
|
Gingival crevicular fluid MMP-8 levels
Periodo de tiempo: Baseline
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gingival Index
Periodo de tiempo: Baseline
|
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3: 0 = normal gingiva
|
Baseline
|
|
Plaque Index
Periodo de tiempo: Baseline
|
Dental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3: 0 = no plaque
|
Baseline
|
|
Bleeding on Probing Scores Assessed by Periodontal Probing
Periodo de tiempo: Baseline
|
Bleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously: 0 = absence of bleeding 1 = presence of bleeding Higher scores indicate greater gingival inflammation. |
Baseline
|
|
Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe
Periodo de tiempo: Baseline
|
Periodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth.
Higher values indicate deeper periodontal pockets and worse periodontal condition.
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NigdeOHU-GingivitisDOS
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.
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. .