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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiruni University

About this trial

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 soluable CD163 (sCD163), B cell activating factor (BAFF), tumor necrosis factor-like weak inducer of apoptosis (TWEAK), a proliferation-inducing ligand (APRIL), interferon-gamma (IFN-γ), interleukin-10 (IL-10), interleukin-34 (IL-34), interleukin-35 (IL-35), and arginase activity (ornithine levels) 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who is suitable for the peri-implantitis diagnosis according to the classifications of periodontal and peri-implant diseases and conditions established in 2017.

Individuals with at least one bone-level dental implant and scheduled to undergo exposure surgery.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 4 trial groups
Group A: Peri-implant health - smokers
Group B: Peri-implant health - non-smokers
Group C: Peri-implantitis - non-smokers
Group D: Peri-implantitis - smokers

Trial outcomes

Primary outcomes

1

Evaluation of soluable CD163 (sCD163) levels

sCD163 levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.

Time frame
Baseline
2

Evaluation of a proliferation-inducing ligand (APRIL) levels

APRIL levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.

Time frame
Baseline
3

Evaluation of B-cell activating factor (BAFF) levels

BAFF levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.

Time frame
Baseline
4

Evaluation of tumor necrosis factor-like weak inducer of apoptosis (TWEAK) levels

TWEAK levels in tissue samples collected from the participants will be evaluated using Bio-Plex multiplex kits. The results of the biochemical analyses will be reported as pg/ng.

Time frame
Baseline

Secondary outcomes

1

Probable pocket depth (PPD)

Probable pocket depth wiil be measured using a periodontal probe

Time frame
Baseline and 6th week.
2

Bleeding on probing (BoP)

The presence of visible bleeding following periodontal probing will be assessed by visual inspection (+/-). The total bleeding score will be expressed as a percentage.

Time frame
Baseline and 6th week.
3

Plaque index

The presence of visible plaque will be evaluated with a periodontal probe (+/-). The total plaque score will be expressed as a percentage.

Time frame
Baseline and 6th week.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biruni University

Lead sponsor

University of Turku

Collaborator

The Scientific and Technological Research Council of Turkey

Collaborator