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

20 de maio de 2026 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

48

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

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

Colaboradores e Investigadores

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Patrocinador

Investigadores

  • Cadeira de estudo: Cüneyt A Aral, Professor, DDS, PhD, Inonu University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de janeiro de 2024

Conclusão Primária (Real)

1 de janeiro de 2025

Conclusão do estudo (Real)

1 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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