Evaluation of Gingival Tissue Protein Levels of Serum Amyloid A Family Members
The primary aim of this study is to determine the serum amyloid A (SAA) family protein levels in gingival tissue samples obtained from periodontally healthy and periodontitis patients and to evaluate their relationship with periodontal status. Additionally, the study aims to assess the potential effect of smoking on the amount of SAA proteins in gingival tissue.
Following ethical committee approval, a total of 108 individuals aged 18-65 years who attending to the Department of Periodontology, Biruni University Faculty of Dentistry, will be included in the study. The study groups will consist of 27 non-smoking individuals with periodontally healthy tissue, 27 smoking individuals with periodontally healthy tissue, 27 non-smoking individuals with stage III grade B periodontitis, and 27 smoking individuals with stage III grade C periodontitis. The non-smoking groups will include individuals who have never smoked, while the smoking groups will include individuals who, according to patient statements, have smoked at least 10 cigarettes per day for more than five years.
All participants will be informed about the study and their written consent will be obtained. Plaque score, probing depth, gingival margin position, clinical attachment level, and bleeding on probing will be measured by a calibrated investigator. Gingival tissue samples from periodontally healthy individuals will be collected during planned tooth extraction or periodontal surgical procedures such as gingivoplasty, gingivectomy, or clinical crown lengthening, independent of the study. Only gingival tissues that would otherwise be discarded as medical waste during routine treatment will be used. In individuals with periodontitis, granulation tissue removed during subgingival instrumentation as part of non-surgical periodontal treatment is planned for use. No additional tissue will be removed from the periodontal pocket wall or junctional epithelium for research purposes; the scope of the clinical procedure will not be expanded if suitable tissue cannot be obtained.
Gingival tissue samples will only be collected initially, stored at -80°C until the day of analysis, and evaluated using the ELISA method.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Burcu Karaduman
- Número de teléfono: +905323763366
- Correo electrónico: bkaraduman@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Asena Kadayıf Can
- Número de teléfono: +905382571317
- Correo electrónico: asenakadayif@outlook.com
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Biruni University, who meet the study eligibility criteria. A total of 108 participants will be included in four groups of 27: periodontally healthy never smokers, periodontally healthy smokers, never smokers with stage III grade B periodontitis, and smokers with stage III grade C periodontitis. Periodontally healthy participants must have an independent clinical indication for tooth extraction or periodontal surgery during which gingival tissue would otherwise be discarded.
Descripción
Inclusion Criteria:
- Participants must meet the periodontal disease and health criteria,
- Be between 18-65 years of age,
- Periodontally healthy participants must have an indication for tooth extraction or surgical periodontal treatment where a gingival tissue sample can be collected as part of the treatment plan,
- Not have a systemic disease that may affect the pathogenesis of periodontal disease,
- Not be pregnant or breastfeeding,
- Not be using any medication that may affect the immune system,
- Not have used antibiotics or anti-inflammatory drugs in the last 3 months,
- Not have received any periodontal treatment in the last 3 months.
Exclusion Criteria:
- Having diseases that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
- Using medications that may affect periodontal tissues, the course of periodontal disease, and the response to periodontal treatment,
- Being pregnant or breastfeeding,
- Chronic alcohol use,
- Using antibiotics or anti-inflammatory drugs within the last 3 months,
- Having received periodontal treatment within the last 3 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: CROSS_SECTIONAL
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
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Periodontally Healthy Non-smokers
Twenty-seven adults aged 18-65 years who have never smoked, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease. |
|
Periodontally Healthy Smokers
Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years, with periodontal health on an intact periodontium, probing depths ≤3 mm, bleeding on probing at <10% of sites, no radiographic bone loss, and no history of periodontal disease. |
|
Stage III Grade B Periodontitis
Twenty-seven adults aged 18-65 years who have never smoked and have stage III grade B periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0. |
|
Stage III Grade C Periodontitis
Twenty-seven adults aged 18-65 years who report smoking ≥10 cigarettes per day for more than 5 years and have stage III grade C periodontitis. Clinical criteria include clinical attachment loss ≥5 mm at ≥2 nonadjacent teeth, radiographic bone loss extending to the middle third of the root or beyond, loss of ≤4 teeth due to periodontitis, probing depths ≥6 mm, vertical bone loss ≥3 mm, and ≥20 remaining teeth. The percentage radiographic bone loss-to-age ratio will be 0.25-1.0; grade C classification will be based on smoking ≥10 cigarettes per day as a grade modifier. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gingival tissue SAA1 concentration
Periodo de tiempo: Baseline
|
SAA1 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL. |
Baseline
|
|
Gingival tissue SAA2 concentration
Periodo de tiempo: Baseline
|
SAA2 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL. |
Baseline
|
|
Gingival tissue SAA3 concentration
Periodo de tiempo: Baseline
|
SAA3 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL. |
Baseline
|
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Gingival tissue SAA4 concentration
Periodo de tiempo: Baseline
|
SAA4 concentration in gingival tissue homogenates will be measured by ELISA (FineTest) according to the manufacturer's instructions and reported in ng/mL. |
Baseline
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Gingival Tissue SAA Protein Levels and Probing Depth
Periodo de tiempo: Baseline
|
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and probing depth, measured in millimeters (mm). |
Baseline
|
|
Correlation Between Gingival Tissue SAA Protein Levels and Plaque Score
Periodo de tiempo: Baseline
|
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and plaque score, expressed as the percentage, of examined sites with plaque. |
Baseline
|
|
Correlation Between Gingival Tissue SAA Protein Levels and Bleeding on Probing
Periodo de tiempo: Baseline
|
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and bleeding on probing, expressed as the percentage of examined sites exhibiting bleeding after probing. |
Baseline
|
|
Correlation Between Gingival Tissue SAA Protein Levels and Clinical Attachment Level
Periodo de tiempo: Baseline
|
Correlation between gingival tissue serum amyloid A (SAA) family protein levels and clinical attachment level, measured in millimeters. |
Baseline
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- SAA-GT-2026-11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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