PeriodontitisNCT07826728
SMOKING AND GINGIVAL CREVICULAR FLUID MFN1 AND NLRP3 LEVELS IN PERIODONTAL HEALTH AND PERIODONTITIS
An observational study of Periodontitis and Smoking, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to examine the relationship between cigarette smoking and the levels of two proteins, mitofusin-1 (MFN1) and NLRP3, in the fluid found between the teeth and gums. These proteins are involved in processes related to cell function and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Smoking
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, Bolu, Türkiye, will be assessed for eligibility. Participants will have at least 20 natural teeth and either periodontal health on an intact periodontium or Stage III or Stage IV periodontitis. Four groups will be formed according to periodontal status and cigarette smoking history: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis.
Who may be able to join
- Aged 18-65 years. At least 20 natural teeth. For the periodontal health groups: periodontal health on an intact periodontium, with probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis.
- For the periodontitis groups: Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification.
- For the smoking groups: current cigarette smoking of at least 10 cigarettes per day for at least 5 years.
- For the nonsmoking groups: fewer than 100 cigarettes smoked during the lifetime and no current use of tobacco or nicotine products.
- Provision of written informed consent.
Who cannot join
- ormer cigarette smoking. Use of electronic cigarettes, heated tobacco products, nicotine pouches, or nicotine replacement products.
- Uncontrolled diabetes, immunodeficiency, autoimmune or chronic inflammatory disease, or a serious systemic disease that may affect periodontal or mitochondrial responses.
- Pregnancy or breastfeeding. Use of antibiotics, systemic corticosteroids, immunosuppressive medications, or regular anti-inflammatory medications within the previous 3 months.
- Periodontal treatment within the previous 6 months. Acute oral infection, periodontal abscess, or local pathology affecting the sampling sites.
- Gingival crevicular fluid samples contaminated with blood or saliva, or insufficient for ELISA analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
Bolu, Central, 14100
Zeynep Akgul, 05304253826
About this study
Official title: ASSOCİATİON BETWEEN SMOKİNG AND GİNGİVAL CREVİCULAR FLUİD MFN1 AND NLRP3 LEVELS İN INDİVİDUALS WİTH PERİODONTAL HEALTH OR PERİODONTİTİS
This observational study aims to examine the relationship between cigarette smoking and the levels of two proteins, mitofusin-1 (MFN1) and NLRP3, in the fluid found between the teeth and gums. These proteins are involved in processes related to cell function and inflammation.
Adults aged 25-65 years will be included in four groups: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis. Periodontitis is a gum disease that damages the tissues and bone supporting the teeth.
Read more
Participants will provide information about their health and smoking history and undergo a periodontal examination. Small samples of fluid from around the gums will be collected using paper strips before periodontal treatment. The samples will be analyzed for MFN1 and NLRP3.
Researchers will compare the amounts of these proteins across the four groups and examine their relationships with periodontal measurements and smoking history. No experimental medication or treatment will be assigned. Participants with periodontitis will be offered routine periodontal care after sample collection.
- Conditions
- Periodontitis, Smoking
- Keywords
- Periodontal health, Gingival crevicular fluid, Mitofusin-1, MFN1, NLRP3, Smoking exposure
- Medical subject headings
- Periodontitis, 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 |
|---|---|---|
| Periodontally Healthy Nonsmokers | Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3. | |
| Periodontally Healthy Smokers | Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3. | |
| Nonsmokers With Periodontitis | Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection. | |
| Smokers With Periodontitis | Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will be current smokers who have regularly smoked at least 10 cigarettes per day for at least 5 years. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of MFN1 in Gingival Crevicular Fluid
The total amount of mitofusin-1 (MFN1) in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). MFN1 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.
Measured: Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.
Secondary outcomes (6)
Total Amount of NLRP3 in Gingival Crevicular Fluid
The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.
Measured: The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodonti
Full-Mouth Mean Probing Depth
Probing depth will be measured in millimeters from the gingival margin to the base of the sulcus or periodontal pocket at six sites per tooth, excluding third molars. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.
Measured: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Clinical Attachment Level
Clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the sulcus or periodontal pocket at six sites per tooth, excluding third molars. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.
Measured: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Percentage of Sites With Bleeding on Probing
Bleeding on probing will be recorded at six sites per tooth, excluding third molars. The number of bleeding sites will be divided by the total number of examined sites and multiplied by 100 to calculate a full-mouth percentage for each participant. Scores range from 0% to 100%, with higher values indicating more widespread gingival bleeding. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.
Measured: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Plaque Index
Full-Mouth Mean Plaque Index
Measured: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Gingival Index
Gingival inflammation will be assessed using the Löe and Silness Gingival Index at four surfaces per tooth, excluding third molars. Scores range from 0 to 3, with higher scores indicating more severe gingival inflammation. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.
Measured: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Aug 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep AKGÜL, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826728
- Sponsor's protocol ID
- BAİBU-Perio-ZA-04
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
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
- ASSOCİATİON BETWEEN SMOKİNG AND GİNGİVAL CREVİCULAR FLUİD MFN1 AND NLRP3 LEVELS İN INDİVİDUALS WİTH PERİODONTAL HEALTH OR PERİODONTİTİS
- ClinicalTrials.gov ID
- NCT07826728
- Acronym / sponsor ID
- BAİBU-Perio-ZA-04
- Conditions
- Periodontitis, Smoking
- Keywords
- Periodontal health, Gingival crevicular fluid, Mitofusin-1, MFN1, NLRP3, Smoking exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 17 Sep 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.
This observational study aims to examine the relationship between cigarette smoking and the levels of two proteins, mitofusin-1 (MFN1) and NLRP3, in the fluid found between the teeth and gums. These proteins are involved in processes related to cell function and inflammation.
Adults aged 25-65 years will be included in four groups: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis. Periodontitis is a gum disease that damages the tissues and bone supporting the teeth.
Participants will provide information about their health and smoking history and undergo a periodontal examination. Small samples of fluid from around the gums will be collected using paper strips before periodontal treatment. The samples will be analyzed for MFN1 and NLRP3.
Researchers will compare the amounts of these proteins across the four groups and examine their relationships with periodontal measurements and smoking history. No experimental medication or treatment will be assigned. Participants with periodontitis will be offered routine periodontal care after sample collection.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy Nonsmokers | – | –Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3. |
| Periodontally Healthy Smokers | – | –Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3. |
| Nonsmokers With Periodontitis | – | –Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection. |
| Smokers With Periodontitis | – | –Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will be current smokers who have regularly smoked at least 10 cigarettes per day for at least 5 years. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, Bolu, Türkiye, will be assessed for eligibility. Participants will have at least 20 natural teeth and either periodontal health on an intact periodontium or Stage III or Stage IV periodontitis. Four groups will be formed according to periodontal status and cigarette smoking history: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis.
Key inclusion criteria (5 listed)
- Aged 18-65 years. At least 20 natural teeth. For the periodontal health groups: periodontal health on an intact periodontium, with probing depths ≤3 mm, full-mouth bleeding on probing <10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis.
- For the periodontitis groups: Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification.
- For the smoking groups: current cigarette smoking of at least 10 cigarettes per day for at least 5 years.
- For the nonsmoking groups: fewer than 100 cigarettes smoked during the lifetime and no current use of tobacco or nicotine products.
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- ormer cigarette smoking. Use of electronic cigarettes, heated tobacco products, nicotine pouches, or nicotine replacement products.
- Uncontrolled diabetes, immunodeficiency, autoimmune or chronic inflammatory disease, or a serious systemic disease that may affect periodontal or mitochondrial responses.
- Pregnancy or breastfeeding. Use of antibiotics, systemic corticosteroids, immunosuppressive medications, or regular anti-inflammatory medications within the previous 3 months.
- Periodontal treatment within the previous 6 months. Acute oral infection, periodontal abscess, or local pathology affecting the sampling sites.
- Gingival crevicular fluid samples contaminated with blood or saliva, or insufficient for ELISA analysis.
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
Total Amount of MFN1 in Gingival Crevicular Fluid
Time frame: Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.
The total amount of mitofusin-1 (MFN1) in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). MFN1 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.
6 secondary outcomes
Total Amount of NLRP3 in Gingival Crevicular Fluid
Time frame: The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodonti
Full-Mouth Mean Probing Depth
Time frame: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Clinical Attachment Level
Time frame: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Percentage of Sites With Bleeding on Probing
Time frame: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Plaque Index
Time frame: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
Full-Mouth Mean Gingival Index
Time frame: Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.
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: No
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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.
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 Periodontitis and Smoking, run by Abant Izzet Baysal 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 5 inclusion and 5 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 Zeynep Akgul, DDS, PhD (05304253826, zeyneppakgulakgul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of MFN1 in Gingival Crevicular Fluid (time frame: Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.). 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.