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

20 мая 2026 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

48

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

    • Malatya
      • Malatya, Malatya, Турция (Туркие), 44210
        • Inönü University Faculty of Dentistry, Department of Periodontology

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Метод выборки

Невероятностная выборка

Исследуемая популяция

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).

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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.

Что измеряет исследование?

Первичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Учебный стул: Cüneyt A Aral, Professor, DDS, PhD, Inonu University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

10 января 2024 г.

Первичное завершение (Действительный)

1 января 2025 г.

Завершение исследования (Действительный)

1 апреля 2025 г.

Даты регистрации исследования

Первый отправленный

13 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

20 мая 2026 г.

Первый опубликованный (Действительный)

22 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • IUCTEC.2024/06
  • TDH-2024-3464 (Другой номер гранта/финансирования: Inönü University Scientific Research Projects Coordination Office)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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