Markers of Bone Destruction and Oxidative Stress in Peri-implantitis

NCT07397884 | Not Yet Recruiting

• 1 other identifier: 2025-403
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases; Periimplant Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (6)

• 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)

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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) -

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Periodontal Diseases; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Gülbahar Ustaoğlu, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurullah Yurdakul, Dr.

CONTACT

+905340757662; nurullah.yurdakul@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share