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Markers of Bone Destruction and Oxidative Stress in Peri-implantitis

Evaluation of Bone Destruction and Oxidative Stress Markers in Saliva and Peri-implant Sulcus Fluid in Peri-implantitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07397884
Enrollment
80
Registered
2026-02-09
Start date
2026-02-15
Completion date
2026-09-15
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periimplant Diseases, Periodontal Diseases

Keywords

Periodontal Diseases, periimplant diseases, Oxidative Stress, Alveolar Bone Loss

Brief summary

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.

Interventions

None listed

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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). \-

Design outcomes

Primary

MeasureTime frameDescription
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.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.

Secondary

MeasureTime frameDescription
Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine LevelsBaseline (at the time of clinical examination)Concentration of Nitrotyrosine will be measured in saliva and PISF samples using ELISA kits. Nitrotyrosine serves as a biochemical marker of nitrosative stress to evaluate oxidative damage.
Salivary and Peri-implant Sulcular Fluid (PISF) NQO1 LevelsBaseline (at the time of clinical examination)NAD(P)H: Quinone Oxidoreductase 1 (NQO1) levels will be measured using ELISA kits to assess the local and systemic antioxidant defense response.
Salivary and Peri-implant Sulcular Fluid (PISF) RANKL LevelsBaseline (at the time of clinical examination)Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) levels will be measured to evaluate osteoclast activation and bone destruction potential.
Salivary and Peri-implant Sulcular Fluid (PISF) OPG LevelsBaseline (at the time of clinical examination)Osteoprotegerin (OPG) levels will be measured. OPG acts as a decoy receptor for RANKL, and its level indicates the body's attempt to inhibit bone resorption.
Clinical Attachment Loss (CAL) and Probing Depth (PD)Baseline (at the time of clinical examination)CAL and PD will be measured in millimeters (mm) at six sites per tooth/implant using a Williams periodontal probe to assess the severity of tissue destruction.
Plaque Index (PI) and Gingival Index (GI)Baseline (at the time of clinical examination)PI and GI will be recorded using Silness-Löe and Löe-Silness indices (scored 0-3) to evaluate oral hygiene status and gingival inflammation.

Countries

Turkey (Türkiye)

Contacts

CONTACTNurullah Yurdakul, Dr.
nurullah.yurdakul@sbu.edu.tr+905340757662
PRINCIPAL_INVESTIGATORGülbahar Ustaoğlu, Professor

University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026