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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoking on Th1/Th2-M1/M2 Cytokine Balance and B-Cell Immune Responses in Peri-Implant Health and Disease
- ClinicalTrials.gov ID
- NCT07750171
- Acronym / sponsor ID
- 20
- Keywords
- Peri-implantitis, Host immune response, Smoking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aysen Bodur, Professor contact
Buse Naz Büyükakçalı, DDS principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implant Health and Peri Implant Mucositis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buse Naz Büyükakçalı, DDS (+905448024169, busenazbuyukakcali@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant crevicular fluid levels of Th1/Th2-, M1/M2-, and B-cell-related immune markers (time frame: At a single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.