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

20 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

48

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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).

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Cüneyt A Aral, Professor, DDS, PhD, Inonu University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 gennaio 2024

Completamento primario (Effettivo)

1 gennaio 2025

Completamento dello studio (Effettivo)

1 aprile 2025

Date di iscrizione allo studio

Primo inviato

13 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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