Evaluation of Bone Destruction and Oxidative Stress Markers in Saliva and Peri-implant Sulcus Fluid in Peri-implantitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy volunteers aged 18-
- •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) -
排除标准
- •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).
研究组 & 干预措施
Periodontitis Group
Patients with at least one tooth having clinical probing depth ≥ 4 mm, presence of bleeding on probing (BOP), and evidence of radiographic alveolar bone loss.
Peri-implantitis Group
Patients with at least one dental implant in function for at least 1 year, showing signs of inflammation (BOP/suppuration), probing depth (PD) ≥ 5 mm, and radiographic bone loss ≥ 2 mm.
Peri-implant Health Group
Patients with implants in function for at least 1 year, showing no signs of inflammation (no BOP), probing depth ≤ 3 mm, and no radiographic bone loss.
Periodontal Health Group
Systemically healthy individuals with clinical probing depths ≤ 3 mm, minimal plaque and bleeding scores, and no radiographic evidence of bone loss.
结局指标
主要结局
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.
时间窗: At the baseline clinical examination (Day 0).
The concentration of Interleukin-1 beta (IL-1β), a pro-inflammatory cytokine, will be measured in picograms per milliliter (pg/mL) using ELISA kits to evaluate the severity of inflammation and bone destruction.
次要结局
- Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine Levels(Baseline (at the time of clinical examination))
- Salivary and Peri-implant Sulcular Fluid (PISF) NQO1 Levels(Baseline (at the time of clinical examination))
- Salivary and Peri-implant Sulcular Fluid (PISF) RANKL Levels(Baseline (at the time of clinical examination))
- Salivary and Peri-implant Sulcular Fluid (PISF) OPG Levels(Baseline (at the time of clinical examination))
- Clinical Attachment Loss (CAL) and Probing Depth (PD)(Baseline (at the time of clinical examination))
- Plaque Index (PI) and Gingival Index (GI)(Baseline (at the time of clinical examination))
研究者
Gülbahar Ustaoğlu
Professor
Saglik Bilimleri Universitesi