Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis

NCT07569432 | Not Yet Recruiting

• 1 other identifier: 2024-BIAEK/16-60
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a chronic inflammatory disease characterized by plaque-associated inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants, which may ultimately lead to implant failure if left untreated. It has been demonstrated that cellular and molecular responses of the host immune defense system play a critical role in the pathogenesis of peri-implantitis. Macrophages are key cells in the host immune response and are generally classified into two phenotypes: pro-inflammatory (M1) and anti-inflammatory (M2). While M1 macrophages are actively involved in the early defense response, a shift toward the M2 phenotype is required for the resolution of inflammation and tissue repair. Smoking has been shown to adversely affect macrophage polarization and function, thereby exacerbating inflammatory responses. Therefore, in the present study, levels of sCD163, BAFF, TWEAK, APRIL, IFN-γ, IL-10, IL-34, IL-35, and arginase activity (ornithine) will be evaluated in peri-implant health and peri-implantitis patients with varying disease severity and different smoking statuses. In addition, a comprehensive proteomic analysis will be performed to investigate the relationships among peri-implantitis severity, smoking, and macrophage polarization-related molecules. Baseline periodontal and peri-implant parameters will be recorded for all participants. In the peri-implant health group, tissue samples will be collected during exposure surgery performed for submerged implants, after which participants will be enrolled in supportive peri-implant care. Participants diagnosed with peri-implantitis will receive non-surgical therapy, during which tissue samples will be collected. Periodontal and peri-implant parameters will be reassessed for all participants at baseline, and at 6 and 12 weeks. Healthy peri-implant samples will be collected from submerged implants during exposure surgery. Peri-implantitis samples (probable pocket depth ≥ 6 mm with bleeding on probing) will be obtained during non-surgical therapy using a single stroke along the pocket wall.

Conditions

Peri-implantitis

Keywords

peri-implantitis; smoking; macrophage

Outcome Measures

Primary Outcomes (1)

• Biochemical Outcomes

  Analysis of tissue levels of sCD163, BAFF, TWEAK, APRIL, IFN-γ, IL-10, IL-34, IL-35 and arginase activity (ornithine levels).

  Baseline

Secondary Outcomes (3)

• Probable pocket depth (PPD)

  Baseline, 6th and 12th week.

• Bleeding on probing (BoP)

  Baseline 6th and 12th week

• Plaque index

  Baseline, 6th and 12th week.

Study Arms (4)

Peri-implant health - smokers

Individuals with at least one bone-level dental implant, who are current smokers, and are scheduled to undergo exposure surgery.

Peri-implant health - non-smokers

Individuals with at least one bone-level dental implant, who are non-smokers, and are scheduled to undergo exposure surgery.

Peri-implantitis - non-smokers

Individuals with peri-implantitis (non-smokers) were defined as subjects who were non-smokers and presented with bleeding and/or suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant, in accordance with the case definitions proposed by Berglundh et al. (2018) and Schwarz et al. (2018).

Peri-implantitis - smokers

Individuals with peri-implantitis (smokers) were defined as subjects who were current smokers and presented with bleeding and/or suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant, in accordance with the case definitions proposed by Berglundh et al. (2018) and Schwarz et al. (2018).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who applied to Biruni University Faculty of Dentistry for treatment or oral examination will be included in this study.

You may qualify if:

• Individuals who is suitable for the peri-implantitis diagnosis according to the classifications of periodontal and peri-implant diseases and conditions established in 2018 (Berglundh et al., 2018; Tonetti et al., 2018).
• Individuals with at least one bone-level dental implant and scheduled to undergo exposure surgery.

You may not qualify if:

• prior peri-implantitis surgery
• being diagnosed with autoimmune disease, genetic disorders, bone metabolism disorders, poorly controlled systemic diseases (such as diabetes or hypertension)
• pregnancy or lactation
• having a history of oral malignancy, chemotherapy or radiotherapy
• use of anti-inflammatory drugs within 2 weeks, antibiotics within 3 months,
• need for prophylactic antibiotics
• contraindications for dental/surgical procedures.

Sponsors & Collaborators

• Biruni University: lead
• University of Turku: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples

MeSH Terms

Conditions

Peri-Implantitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Burcu Karaduman, PhD

  Biruni University

  STUDY CHAIR

• Ulvi K Gursoy, PhD

  University of Turku

  STUDY CHAIR

• Mustafa Yilmaz, PhD

  Istanbul University

  STUDY CHAIR

• Ayse Kaban

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)