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MERC Proteins in Saliva and GCF in Periodontal Disease (ELISA Study) (EKNMERC-GCF-SL)

20 de mayo de 2026 actualizado por: Cuneyt Asim Aral, Inonu University

Expression of Mitochondria-Endoplasmic Reticulum Contact Proteins in Saliva and Gingival Crevicular Fluid in Patients With Periodontal Disease: ELISA and Calcium Analysis

This observational cross-sectional study investigates the levels of mitochondria-endoplasmic reticulum contact site (MERC) proteins in saliva and gingival crevicular fluid (GCF) of individuals with different periodontal conditions. MERCs are specialized regions where mitochondria and the endoplasmic reticulum physically connect, and they play important roles in calcium signaling, oxidative stress regulation, and cell death (apoptosis). Disruption of these contact sites has been linked to inflammatory diseases, including periodontal disease.

The study includes 48 systemically healthy, non-smoking adults divided into three groups: periodontally healthy (n=16), gingivitis (n=16), and Stage III Grade B periodontitis (n=16). Five MERC-associated proteins (VAPB, PTPIP51, IP3R, GRP75, and VDAC) are measured in GCF and saliva samples using ELISA. Additionally, caspase-3 (a marker of apoptosis), reactive oxygen species (a marker of oxidative stress), and calcium levels are measured to explore relationships between MERC proteins and key cellular processes involved in periodontal tissue destruction.

The purpose of this study is to determine whether MERC protein levels differ across periodontal conditions and to evaluate their associations with clinical periodontal parameters, oxidative stress, calcium metabolism, and apoptosis.

Descripción general del estudio

Descripción detallada

Mitochondria-endoplasmic reticulum contact sites (MERCs) are specialized structural domains that physically link mitochondria and the endoplasmic reticulum. These contact sites are enriched with functional proteins that coordinate calcium transfer between the two organelles, regulate lipid metabolism, modulate oxidative stress responses, and control apoptotic signaling pathways. Key MERC-associated proteins include VAPB (vesicle-associated membrane protein-associated protein B), PTPIP51 (protein tyrosine phosphatase-interacting protein 51), IP3R (inositol 1,4,5-trisphosphate receptor), GRP75 (glucose-regulated protein 75), and VDAC (voltage-dependent anion channel). The IP3R-GRP75-VDAC complex facilitates calcium transfer from the ER to mitochondria, while the VAPB-PTPIP51 complex modulates this process and influences ATP production and autophagy. Disruption of MERC homeostasis has been implicated in neurodegenerative diseases, metabolic disorders, and periodontal disease. Periodontal disease is a chronic inflammatory condition driven by microbial dental plaque, leading to destruction of periodontal tissues and alveolar bone. Previous studies demonstrated dysregulation of MERC-related gene expression (MFN1, IP3R, GRP75, PINK1, SIGMAR1) in human gingival fibroblasts exposed to Porphyromonas gingivalis and Fusobacterium nucleatum.

The present study measures the concentrations and total amounts of five MERC proteins-VAPB, PTPIP51, IP3R, GRP75, and VDAC-together with caspase-3 (an apoptosis marker), reactive oxygen species (ROS, an oxidative stress marker), and calcium levels in gingival crevicular fluid (GCF) and unstimulated whole saliva obtained from systemically healthy, non-smoking participants. Participants are classified into three groups according to the 2017 World Workshop classification: periodontally healthy (n=16), gingivitis (n=16), and Stage III Grade B periodontitis (n=16), with equal sex distribution (8 males and 8 females per group). GCF samples are collected from three single-rooted teeth per participant using standardized paper strips (Periopaper), with absorbed volume measured using a Periotron 8000. Saliva samples are collected using the passive drooling method. Biomarker levels are quantified using commercially available ELISA kits. Clinical periodontal parameters recorded include Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), Bleeding on Probing (BOP%), and Clinical Attachment Level (CAL). Correlations between biomarker levels and clinical parameters are analyzed. Receiver operating characteristic (ROC) curve analysis is performed to evaluate the diagnostic potential of the biomarkers.

Tipo de estudio

De observación

Inscripción (Actual)

48

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Malatya
      • Malatya, Malatya, Turquía (Türkiye), 44210
        • Inönü University Faculty of Dentistry, Department of Periodontology

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Método de muestreo

Muestra no probabilística

Población de estudio

Systemically healthy, non-smoking individuals aged 18-65 years who presented to the Department of Periodontology, Faculty of Dentistry, Inonu University, Malatya, Turkiye for examination and/or treatment between January 2024 and May 2024. Participants were classified into three groups based on the 2017 World Workshop criteria: periodontally healthy (n=16), gingivitis (n=16), and Stage III Grade B periodontitis (n=16), with equal sex distribution (8 males and 8 females per group).

Descripción

Inclusion Criteria:

  • Systemically healthy individuals aged 18-65 years
  • Non-smokers or smoking cessation more than 5 years ago
  • Healthy group: No history of periodontal disease, ≥20 teeth, probing depth (PD) ≤3 mm at all sites, bleeding on probing (BOP) <10%, radiographic CEJ-to-alveolar bone crest distance ≤3 mm in ≥95% of teeth
  • Gingivitis group: No history of periodontal disease, ≥20 teeth, PD ≤3 mm at all sites, BOP ≥30%, radiographic CEJ-to-alveolar bone crest distance ≤3 mm in ≥95% of teeth
  • Periodontitis group: ≥15 teeth, >30% of teeth affected by periodontal disease, PD ≥6 mm, clinical attachment loss (CAL) ≥5 mm, vertical bone loss ≥3 mm, Class II or III furcation involvement, radiographic alveolar bone loss extending to the middle third or beyond (≥33%), bone loss-to-age ratio between 0.25 and 1.00

Exclusion Criteria:

  • Periodontal treatment or antibiotic use within the past 6 months
  • Fewer than 20 teeth (excluding third molars)
  • Presence of any systemic disease
  • Current smoking or cessation within the past 5 years
  • Use of immunosuppressive medication
  • Alcohol consumption
  • Regular medication use
  • Pregnancy or lactation
  • Need for antibiotic prophylaxis prior to dental procedures
  • Prosthetic restorations on the teeth selected for sampling

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
Periodontally Healthy
Systemically healthy, non-smoking individuals with no history of periodontal disease. Inclusion criteria: ≥20 teeth, probing depth (PD) ≤3 mm at all sites, bleeding on probing (BOP) <10%, and radiographic CEJ-to-alveolar bone crest distance ≤3 mm in ≥95% of teeth. n=16 (8 females, 8 males).
Levels of MERC-associated proteins (VAPB, PTPIP51, IP3R, GRP75, VDAC), caspase-3, reactive oxygen species, and calcium were measured in gingival crevicular fluid and unstimulated whole saliva samples using commercially available ELISA kits. Absorbance was read at 450 nm. No therapeutic intervention was applied; this is an observational biomarker measurement study.
Calcium levels were measured in gingival crevicular fluid and unstimulated whole saliva samples using a commercially available ELISA kit (ELK Biotechnology, China). Concentrations were expressed as μmol/mL and total amounts as μmol/30s. Analytical range: 0.15-40 μmol/mL. No therapeutic intervention was applied.
Gingivitis
Systemically healthy, non-smoking individuals with gingival inflammation but no attachment loss. Inclusion criteria: ≥20 teeth, PD ≤3 mm at all sites, BOP ≥30%, and radiographic CEJ-to-alveolar bone crest distance ≤3 mm in ≥95% of teeth. n=16 (8 females, 8 males).
Levels of MERC-associated proteins (VAPB, PTPIP51, IP3R, GRP75, VDAC), caspase-3, reactive oxygen species, and calcium were measured in gingival crevicular fluid and unstimulated whole saliva samples using commercially available ELISA kits. Absorbance was read at 450 nm. No therapeutic intervention was applied; this is an observational biomarker measurement study.
Calcium levels were measured in gingival crevicular fluid and unstimulated whole saliva samples using a commercially available ELISA kit (ELK Biotechnology, China). Concentrations were expressed as μmol/mL and total amounts as μmol/30s. Analytical range: 0.15-40 μmol/mL. No therapeutic intervention was applied.
Stage III Grade B Periodontitis
Systemically healthy, non-smoking individuals with Stage III Grade B periodontitis. Inclusion criteria: ≥15 teeth, >30% of teeth affected, PD ≥6 mm, CAL ≥5 mm, vertical bone loss ≥3 mm, Class II/III furcation involvement, radiographic bone loss extending to the middle third or beyond (≥33%), and bone loss-to-age ratio between 0.25 and 1.00. n=16 (8 females, 8 males).
Levels of MERC-associated proteins (VAPB, PTPIP51, IP3R, GRP75, VDAC), caspase-3, reactive oxygen species, and calcium were measured in gingival crevicular fluid and unstimulated whole saliva samples using commercially available ELISA kits. Absorbance was read at 450 nm. No therapeutic intervention was applied; this is an observational biomarker measurement study.
Calcium levels were measured in gingival crevicular fluid and unstimulated whole saliva samples using a commercially available ELISA kit (ELK Biotechnology, China). Concentrations were expressed as μmol/mL and total amounts as μmol/30s. Analytical range: 0.15-40 μmol/mL. No therapeutic intervention was applied.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GCF VAPB Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of VAPB in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary VAPB Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of VAPB (pg/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF PTPIP51 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of PTPIP51 in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary PTPIP51 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of PTPIP51 (ng/L) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF IP3R Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of IP3R in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary IP3R Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of IP3R (ng/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF GRP75 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of GRP75 in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary GRP75 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of GRP75 (ng/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF VDAC Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of VDAC in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary VDAC Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of VDAC (ng/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF Caspase-3 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of caspase-3 (ng/mL) in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary Caspase-3 Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of caspase-3 (ng/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF Reactive Oxygen Species Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of reactive oxygen species (ROS) in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary Reactive Oxygen Species Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of reactive oxygen species (ROS) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
GCF Calcium Levels
Periodo de tiempo: At baseline (single visit)
Concentrations and total amounts of calcium (µmol/mL) in gingival crevicular fluid measured by ELISA.
At baseline (single visit)
Salivary Calcium Levels
Periodo de tiempo: At baseline (single visit)
Concentrations of calcium (µmol/mL) in unstimulated whole saliva measured by ELISA.
At baseline (single visit)
Plaque Index
Periodo de tiempo: At baseline (single visit)
Plaque Index (PI) recorded at sampling sites.
At baseline (single visit)
Gingival Index
Periodo de tiempo: At baseline (single visit)
Gingival Index (GI) recorded at sampling sites.
At baseline (single visit)
Probing Depth
Periodo de tiempo: At baseline (single visit)
Probing Depth (PD) recorded at sampling sites.
At baseline (single visit)
Bleeding on Probing
Periodo de tiempo: At baseline (single visit)
Bleeding on Probing (BOP%) recorded at sampling sites.
At baseline (single visit)
Clinical Attachment Level
Periodo de tiempo: At baseline (single visit)
Clinical Attachment Level (CAL) recorded at sampling sites.
At baseline (single visit)
Gingival Crevicular Fluid Volume
Periodo de tiempo: At baseline (single visit)
Gingival crevicular fluid (GCF) volume measured at sampling sites.
At baseline (single visit)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Silla de estudio: Cüneyt A Aral, Professor, DDS, PhD, Inonu University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

10 de enero de 2024

Finalización primaria (Actual)

1 de enero de 2025

Finalización del estudio (Actual)

1 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

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

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

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. .

Ensayos clínicos sobre Periodontitis

Ensayos clínicos sobre ELISA Biomarker Analysis

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