CompletedNot Applicable

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

Turkey (Türkiye)48 participantsStarted 2024-01-10

Plain-language 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. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study has already been completed and was measuring proteins like VAPB, PTPIP51, and Caspase-3 in saliva and gum fluid — has any of this research led to new ways of testing for or monitoring my gum disease that my care team could use now or in the near future?
2Since this trial focused on discovering and validating biomarkers rather than testing a treatment, does participating in or knowing about this kind of research change anything about how my periodontitis would actually be managed today?
3The study measured things like Reactive Oxygen Species and Calcium levels in gum fluid alongside standard measures like probing depth and bleeding on probing — are any of these biological markers something my dentist or periodontist already tracks, or are they still considered experimental?
4Because this was a biomarker discovery study and not a treatment trial, should I be looking at other studies or standard treatment options that are more directly focused on improving my gum disease outcomes right now?
5The trial measured MERC-related proteins that appear to be linked to cell stress and death pathways — is there anything about my specific diagnosis of periodontitis or gingivitis that would make understanding these biological pathways especially relevant to my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GCF VAPB Levels

Timeframe: At baseline (single visit)

Salivary VAPB Levels

Timeframe: At baseline (single visit)

GCF PTPIP51 Levels

Timeframe: At baseline (single visit)

Salivary PTPIP51 Levels

Timeframe: At baseline (single visit)

GCF IP3R Levels

Timeframe: At baseline (single visit)

Salivary IP3R Levels

Timeframe: At baseline (single visit)

GCF GRP75 Levels

Timeframe: At baseline (single visit)

Salivary GRP75 Levels

Timeframe: At baseline (single visit)

Trial details

NCT IDNCT07601685

SponsorInonu University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Periodontitis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

GCF VAPB Levels

Timeframe: At baseline (single visit)

Salivary VAPB Levels

Timeframe: At baseline (single visit)

GCF PTPIP51 Levels

Timeframe: At baseline (single visit)

Salivary PTPIP51 Levels

Timeframe: At baseline (single visit)

GCF IP3R Levels

Timeframe: At baseline (single visit)

Salivary IP3R Levels

Timeframe: At baseline (single visit)

GCF GRP75 Levels

Timeframe: At baseline (single visit)

Salivary GRP75 Levels

Timeframe: At baseline (single visit)