Peri-Implant HealthNCT07750171
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
An observational study of Peri-Implant Health and Peri Implant Mucositis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Health, Peri Implant Mucositis, Peri-implantitis
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aysen Bodur, Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, Ankara, 06510
Buse Naz Büyükakçalı, +905448024169, busenazbuyukakcali@gazi.edu.tr
About this study
Official title: Impact of Smoking on Th1/Th2-M1/M2 Cytokine Balance and B-Cell Immune Responses in Peri-Implant Health and Disease
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.
- Keywords
- Peri-implantitis, Host immune response, Smoking
- Medical subject headings
- Peri-Implantitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At a single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Buse Naz BÜYÜKAKÇALI ALTAY, Gazi University
- Investigators
- Buse Naz Büyükakçalı, DDS, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750171
- Sponsor's protocol ID
- 20
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided