Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Periodontal Diseases, Periimplant Diseases. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Bone Destruction and Oxidative Stress Markers in Saliva and Peri-implant Sulcus Fluid in Peri-implantitis
Overview
The aim of this study is to evaluate and compare the levels of bone resorption (RANKL, OPG) and oxidative stress (Nitrotyrosine, NQO1) markers, along with pro-inflammatory cytokines (IL-1β), in the saliva and peri-implant sulcular fluid (PISF) of patients with peri-implantitis, periodontitis, and healthy individuals. The study seeks to determine the diagnostic value of these biomarkers in the early detection and progression of peri-implant diseases.
Detailed description
Patients applying to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, will be screened according to the inclusion and exclusion criteria. Following clinical and radiographic examinations, participants will be categorized into four groups (n=20 per group): Periodontitis, Peri-implantitis, Periodontal Health, and Peri-implant Health. All clinical parameters, including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), and Clinical Attachment Loss (CAL), will be recorded at six sites per tooth/implant using a Williams periodontal probe.
The biological sample collection protocol will be conducted as follows:
Saliva Collection: To minimize circadian rhythm variations, unstimulated whole saliva samples (3 ml) will be collected between 9:00 AM and 10:00 AM. Patients will be instructed to refrain from eating, drinking, or oral hygiene procedures for at least one hour prior to collection. Samples will be centrifuged at 1,000g for 10 minutes to remove cellular debris, and the supernatant will be stored at -80°C until laboratory analysis.
Peri-implant Sulcular Fluid (PISF) and Gingival Crevicular Fluid (GCF) Collection: Samples will be obtained from the site with the deepest probing depth in each participant. The area will be isolated with cotton rolls and gently dried with an air syringe to prevent salivary contamination. Periopaper strips will be inserted into the sulcus/pocket for 30 seconds. Strips contaminated with blood or visible saliva will be discarded.
Laboratory Analysis: The concentrations of Interleukin-1 beta (IL-1β), Nitrotyrosine, Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), Osteoprotegerin (OPG), and NAD(P)H: Quinone Oxidoreductase 1 (NQO1) will be quantified in both saliva and PISF/GCF samples using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits according to the manufacturer's instructions.
Primary outcome measures
- Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels. [Time frame: At the baseline clinical examination (Day 0).]
Secondary outcome measures (6)
- Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine Levels [Time frame: Baseline (at the time of clinical examination)]
- Salivary and Peri-implant Sulcular Fluid (PISF) NQO1 Levels [Time frame: Baseline (at the time of clinical examination)]
- Salivary and Peri-implant Sulcular Fluid (PISF) RANKL Levels [Time frame: Baseline (at the time of clinical examination)]
- Salivary and Peri-implant Sulcular Fluid (PISF) OPG Levels [Time frame: Baseline (at the time of clinical examination)]
- Clinical Attachment Loss (CAL) and Probing Depth (PD) [Time frame: Baseline (at the time of clinical examination)]
- Plaque Index (PI) and Gingival Index (GI) [Time frame: Baseline (at the time of clinical examination)]
Eligibility criteria
Inclusion criteria
Systemically healthy volunteers aged 18-65. For Peri-implantitis group: Implants in function for ≥1 year, radiographic bone loss ≥ 2 mm, probing depth (PD) ≥ 5 mm, and presence of bleeding on probing (BOP) or suppuration.
For Periodontitis group: At least one tooth with PD ≥ 4 mm, presence of BOP, and radiographic bone loss.For Healthy groups: PD ≤ 3 mm, no clinical inflammation (BOP-), and no radiographic bone loss.
(According to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases) -
Exclusion Criteria:Presence of systemic diseases (e.g., diabetes, rheumatoid arthritis, osteoporosis).
Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the last 3 months.
Pregnancy or breastfeeding.
Smoking (current smokers).
History of periodontal or peri-implant surgical treatment within the last 6 months.
Implant failure (mobility).
Signs of acute infection (fever, systemic symptoms).
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07397884 · 2025-403