Markers of Bone Destruction and Oxidative Stress in Peri-implantitis

February 2, 2026 updated by: Gülbahar Ustaoğlu, Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who apply to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, and meet the specific clinical and radiographic criteria for peri-implantitis, periodontitis, or health.

Description

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).

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.
Time Frame: 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.
At the baseline clinical examination (Day 0).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine Levels
Time Frame: Baseline (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.
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)
NAD(P)H: Quinone Oxidoreductase 1 (NQO1) levels will be measured using ELISA kits to assess the local and systemic antioxidant defense response.
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)
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) levels will be measured to evaluate osteoclast activation and bone destruction potential.
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)
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.
Baseline (at the time of clinical examination)
Clinical Attachment Loss (CAL) and Probing Depth (PD)
Time Frame: 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.
Baseline (at the time of clinical examination)
Plaque Index (PI) and Gingival Index (GI)
Time Frame: 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.
Baseline (at the time of clinical examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Gülbahar Ustaoğlu, Professor, University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared to protect participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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