PeriodontitisEKNMERC-GCF-SLNCT07601685
MERC Proteins in Saliva and GCF in Periodontal Disease (ELISA Study)
An observational study of Periodontitis and Gingivitis and Periodontal Diseases, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis and Periodontal Diseases, Biomarker Discovery and Validation
- What is being tested?
- ELISA Biomarker Analysis and Calcium Measurement
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Regular medication use
- Pregnancy or lactation
- Need for antibiotic prophylaxis prior to dental procedures
- Prosthetic restorations on the teeth selected for sampling
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inönü University Faculty of Dentistry, Department of Periodontology
Malatya, Malatya, 44210
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Periodontitis, Gingivitis and Periodontal Diseases, Biomarker Discovery and Validation, Pathways
- Being tested
- ELISA Biomarker Analysis, Calcium Measurement
- Keywords
- MERC, Mitochondria-Endoplasmic Reticulum Contact, VAPB, PTPIP51, IP3R, GRP75, VDAC, Caspase-3, Reactive Oxygen Species, Calcium, Gingival Crevicular Fluid, Saliva, ELISA, Oxidative Stress, Apoptosis
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases, Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA Biomarker AnalysisDiagnostic test
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 MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: ELISA Biomarker Analysis; Diagnostic Test: Calcium Measurement | |
| 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). Receives: Diagnostic Test: ELISA Biomarker Analysis; Diagnostic Test: Calcium Measurement | |
| 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). Receives: Diagnostic Test: ELISA Biomarker Analysis; Diagnostic Test: Calcium Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF VAPB Levels
Concentrations and total amounts of VAPB in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary VAPB Levels
Concentrations of VAPB (pg/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF PTPIP51 Levels
Concentrations and total amounts of PTPIP51 in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary PTPIP51 Levels
Concentrations of PTPIP51 (ng/L) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF IP3R Levels
Concentrations and total amounts of IP3R in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary IP3R Levels
Concentrations of IP3R (ng/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF GRP75 Levels
Concentrations and total amounts of GRP75 in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary GRP75 Levels
Concentrations of GRP75 (ng/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF VDAC Levels
Concentrations and total amounts of VDAC in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary VDAC Levels
Concentrations of VDAC (ng/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF Caspase-3 Levels
Concentrations and total amounts of caspase-3 (ng/mL) in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary Caspase-3 Levels
Concentrations of caspase-3 (ng/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF Reactive Oxygen Species Levels
Concentrations and total amounts of reactive oxygen species (ROS) in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary Reactive Oxygen Species Levels
Concentrations of reactive oxygen species (ROS) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
GCF Calcium Levels
Concentrations and total amounts of calcium (µmol/mL) in gingival crevicular fluid measured by ELISA.
Measured: At baseline (single visit)
Salivary Calcium Levels
Concentrations of calcium (µmol/mL) in unstimulated whole saliva measured by ELISA.
Measured: At baseline (single visit)
Plaque Index
Plaque Index (PI) recorded at sampling sites.
Measured: At baseline (single visit)
Gingival Index
Gingival Index (GI) recorded at sampling sites.
Measured: At baseline (single visit)
Probing Depth
Probing Depth (PD) recorded at sampling sites.
Measured: At baseline (single visit)
Bleeding on Probing
Bleeding on Probing (BOP%) recorded at sampling sites.
Measured: At baseline (single visit)
Clinical Attachment Level
Clinical Attachment Level (CAL) recorded at sampling sites.
Measured: At baseline (single visit)
Gingival Crevicular Fluid Volume
Gingival crevicular fluid (GCF) volume measured at sampling sites.
Measured: At baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start10 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, University of Minnesota
- Responsible party
- Principal investigator, Cuneyt Asim Aral, Inonu University
- Investigators
- Cüneyt A Aral, Professor, DDS, PhD, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601685
- Sponsor's protocol ID
- IUCTEC.2024/06
- Other IDs
- TDH-2024-3464
- Acronym
- EKNMERC-GCF-SL
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
PubMed 29926944Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
PubMed 29926490Lim D, Dematteis G, Tapella L, Genazzani AA, Cali T, Brini M, Verkhratsky A. Ca2+ handling at the mitochondria-ER contact sites in neurodegeneration. Cell Calcium. 2021 Sep;98:102453. doi: 10.1016/j.ceca.2021.102453. Epub 2021 Aug 5.
PubMed 34399235Lee S, Min KT. The Interface Between ER and Mitochondria: Molecular Compositions and Functions. Mol Cells. 2018 Dec 31;41(12):1000-1007. doi: 10.14348/molcells.2018.0438. Epub 2018 Dec 12.
PubMed 30590907Kirmizigul OA, Sabanci A, Disli F, Yildiz S, Milward MR, Aral K. Evaluation of the role of mitofusin-1 and mitofusin-2 in periodontal disease. J Periodontol. 2024 Jan;95(1):64-73. doi: 10.1002/JPER.23-0072. Epub 2023 Jul 24.
PubMed 37436713Aral K, Milward MR, Cooper PR. Gene expression profiles of mitochondria-endoplasmic reticulum tethering in human gingival fibroblasts in response to periodontal pathogens. Arch Oral Biol. 2021 Aug;128:105173. doi: 10.1016/j.archoralbio.2021.105173. Epub 2021 May 27.
PubMed 34058723
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Mitochondria-Endoplasmic Reticulum Contact Proteins in Saliva and Gingival Crevicular Fluid in Patients With Periodontal Disease: ELISA and Calcium Analysis
- ClinicalTrials.gov ID
- NCT07601685
- Acronym / sponsor ID
- EKNMERC-GCF-SL / IUCTEC.2024/06
- Conditions
- Periodontitis, Gingivitis and Periodontal Diseases, Biomarker Discovery and Validation, Pathways
- Keywords
- MERC, Mitochondria-Endoplasmic Reticulum Contact, VAPB, PTPIP51, IP3R, GRP75, VDAC, Caspase-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Harvard University, University of Minnesota
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Diagnostic Test: ELISA Biomarker Analysis, Diagnostic Test: Calcium MeasurementSystemically 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). |
| Gingivitis | – | Diagnostic Test: ELISA Biomarker Analysis, Diagnostic Test: Calcium MeasurementSystemically 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). |
| Stage III Grade B Periodontitis | – | Diagnostic Test: ELISA Biomarker Analysis, Diagnostic Test: Calcium MeasurementSystemically 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA Biomarker AnalysisLevels 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. | Diagnostic test | Gingivitis, Periodontally Healthy, Stage III Grade B Periodontitis |
| Calcium MeasurementCalcium 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. | Diagnostic test | Gingivitis, Periodontally Healthy, Stage III Grade B Periodontitis |
Primary outcome
GCF VAPB Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of VAPB in gingival crevicular fluid measured by ELISA.
Salivary VAPB Levels
Time frame: At baseline (single visit)
Concentrations of VAPB (pg/mL) in unstimulated whole saliva measured by ELISA.
GCF PTPIP51 Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of PTPIP51 in gingival crevicular fluid measured by ELISA.
Salivary PTPIP51 Levels
Time frame: At baseline (single visit)
Concentrations of PTPIP51 (ng/L) in unstimulated whole saliva measured by ELISA.
GCF IP3R Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of IP3R in gingival crevicular fluid measured by ELISA.
Salivary IP3R Levels
Time frame: At baseline (single visit)
Concentrations of IP3R (ng/mL) in unstimulated whole saliva measured by ELISA.
GCF GRP75 Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of GRP75 in gingival crevicular fluid measured by ELISA.
Salivary GRP75 Levels
Time frame: At baseline (single visit)
Concentrations of GRP75 (ng/mL) in unstimulated whole saliva measured by ELISA.
GCF VDAC Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of VDAC in gingival crevicular fluid measured by ELISA.
Salivary VDAC Levels
Time frame: At baseline (single visit)
Concentrations of VDAC (ng/mL) in unstimulated whole saliva measured by ELISA.
GCF Caspase-3 Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of caspase-3 (ng/mL) in gingival crevicular fluid measured by ELISA.
Salivary Caspase-3 Levels
Time frame: At baseline (single visit)
Concentrations of caspase-3 (ng/mL) in unstimulated whole saliva measured by ELISA.
GCF Reactive Oxygen Species Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of reactive oxygen species (ROS) in gingival crevicular fluid measured by ELISA.
Salivary Reactive Oxygen Species Levels
Time frame: At baseline (single visit)
Concentrations of reactive oxygen species (ROS) in unstimulated whole saliva measured by ELISA.
GCF Calcium Levels
Time frame: At baseline (single visit)
Concentrations and total amounts of calcium (µmol/mL) in gingival crevicular fluid measured by ELISA.
Salivary Calcium Levels
Time frame: At baseline (single visit)
Concentrations of calcium (µmol/mL) in unstimulated whole saliva measured by ELISA.
Plaque Index
Time frame: At baseline (single visit)
Plaque Index (PI) recorded at sampling sites.
Gingival Index
Time frame: At baseline (single visit)
Gingival Index (GI) recorded at sampling sites.
Probing Depth
Time frame: At baseline (single visit)
Probing Depth (PD) recorded at sampling sites.
Bleeding on Probing
Time frame: At baseline (single visit)
Bleeding on Probing (BOP%) recorded at sampling sites.
Clinical Attachment Level
Time frame: At baseline (single visit)
Clinical Attachment Level (CAL) recorded at sampling sites.
Gingival Crevicular Fluid Volume
Time frame: At baseline (single visit)
Gingival crevicular fluid (GCF) volume measured at sampling sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 29926944Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
- Background: PubMed 29926490Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
- Background: PubMed 34399235Lim D, Dematteis G, Tapella L, Genazzani AA, Cali T, Brini M, Verkhratsky A. Ca2+ handling at the mitochondria-ER contact sites in neurodegeneration. Cell Calcium. 2021 Sep;98:102453. doi: 10.1016/j.ceca.2021.102453. Epub 2021 Aug 5.
- Background: PubMed 30590907Lee S, Min KT. The Interface Between ER and Mitochondria: Molecular Compositions and Functions. Mol Cells. 2018 Dec 31;41(12):1000-1007. doi: 10.14348/molcells.2018.0438. Epub 2018 Dec 12.
- Background: PubMed 37436713Kirmizigul OA, Sabanci A, Disli F, Yildiz S, Milward MR, Aral K. Evaluation of the role of mitofusin-1 and mitofusin-2 in periodontal disease. J Periodontol. 2024 Jan;95(1):64-73. doi: 10.1002/JPER.23-0072. Epub 2023 Jul 24.
- Background: PubMed 34058723Aral K, Milward MR, Cooper PR. Gene expression profiles of mitochondria-endoplasmic reticulum tethering in human gingival fibroblasts in response to periodontal pathogens. Arch Oral Biol. 2021 Aug;128:105173. doi: 10.1016/j.archoralbio.2021.105173. Epub 2021 May 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cüneyt A Aral, Professor, DDS, PhD study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Gingivitis and Periodontal Diseases, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCF VAPB Levels (time frame: At baseline (single visit)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07601685, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.