Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Impact of Smoking on Th1/Th2-M1/M2 Cytokine Balance and B-Cell Immune Responses in Peri-Implant Health and Disease
1 other identifier
observational
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
August 6, 2026
August 1, 2026
4 months
August 3, 2026
August 3, 2026
Conditions
Keywords
Outcome Measures
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
At a single study visit
Study Arms (6)
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.
Smokers With Peri-Implant Mucositis
Participants who smoke and have peri-implant mucositis.
Smokers With Peri-Implantitis
Participants who smoke and have peri-implantitis
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
- University of Turkucollaborator
Study Sites (1)
Gazi University
Ankara, Ankara, 06510, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Buse Naz Büyükakçalı, DDS
Gazi University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 6, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
August 6, 2026
Record last verified: 2026-08