Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-75
SponsorGazi University
About this trial
Peri-implant diseases are inflammatory conditions affecting the gums and bone around dental implants. Peri-implant mucositis causes inflammation in the gums, while peri-implantitis can also lead to bone loss and, in severe cases, implant failure. Smoking is an important risk factor for these conditions because it may change how the immune system responds to inflammation and infection.
This study will compare smokers and non-smokers with healthy dental implants, peri-implant mucositis, or peri-implantitis. Fluid samples will be collected from around the implants to measure proteins involved in inflammation, healing, and immune responses. The aim is to better understand how smoking affects the body's response to peri-implant diseases and to identify biological markers that may help assess disease risk and severity in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
willingness to participate in the study;
having at least one dental implant that has been in function for at least one year;
having an implant diagnosed with peri-implant health, peri-implant mucositis, or initial peri-implantitis according to the study definitions; for the initial peri-implantitis group, having an implant with PD of 6-7 mm.
Disqualifiers
having received periodontal therapy, oral decontamination treatment, antibiotics, or steroids within the last six months before study initiation;
being pregnant or breastfeeding;
having rheumatoid arthritis, lupus erythematosus, or poorly controlled systemic diseases such as diabetes or hypertension;
having a history of radiation therapy or cancer therapy.
Trial population
The study population will consist of adults with at least one dental implant who attend the Department of Periodontology at Gazi University Faculty of Dentistry. Eligible participants will be classified as smokers or non-smokers and further assigned to one of three groups according to their peri-implant condition: peri-implant health, peri-implant mucositis, or peri-implantitis. Participants will be consecutively recruited until the target sample size is reached.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
216 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Non-Smokers With Peri-Implant Health
Group B: Non-Smokers With Peri-Implant Mucositis
Group C: Non-Smokers With Peri-Implantitis
Group D: Smokers With Peri-Implant Health
Group E: Smokers With Peri-Implant Mucositis
Group F: Smokers With Peri-Implantitis
Trial outcomes
Primary outcomes
1
Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers
Peri-implant crevicular fluid samples will be analyzed to determine the levels of IFN-γ, IL-12p70, IL-4, IL-13, IL-10, BAFF, and APRIL. These marker levels will be compared among smokers and non-smokers with peri-implant health, peri-implant mucositis, or peri-implantitis
Time frame
At a single study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gazi University
Lead sponsor
University of Turku
Collaborator
Source ClinicalTrials.gov