Impact of Smoking on Th1/Th2-M1/M2 Cytokine Balance and B-Cell Immune Responses in Peri-Implant Health and Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Gazi University
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Smokers With Peri-Implantitis
Participants who smoke and have peri-implantitis
Smokers With Peri-Implant Mucositis
Participants who smoke and have peri-implant mucositis.
Non-Smokers With Peri-Implant Health
Participants who do not smoke and have clinically healthy peri-implant tissues.
Non-Smokers With Peri-Implant Mucositis
Participants who do not smoke and have peri-implant mucositis.
Non-Smokers With Peri-Implantitis
Participants who do not smoke and have peri-implantitis.
Smokers With Peri-Implant Health
Participants who smoke and have clinically healthy peri-implant tissues.
Outcomes
Primary Outcomes
Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers
Time Frame: At a single study visit
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Buse Naz BÜYÜKAKÇALI ALTAY
Research Assistant
Gazi University