SMOKING AND GINGIVAL CREVICULAR FLUID MFN1 AND NLRP3 LEVELS IN PERIODONTAL HEALTH AND PERIODONTITIS

NCT07826728 | Recruiting

• 1 other identifier: BAİBU-Perio-ZA-04
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periodontitis; Smoking

Keywords

Periodontal health; Gingival crevicular fluid; Mitofusin-1; MFN1; NLRP3; Smoking exposure

Outcome Measures

Primary Outcomes (1)

• 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.

  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 periodonti

• Full-Mouth Mean Probing Depth

  Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.

• Full-Mouth Mean Clinical Attachment Level

  Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.

• Percentage of Sites With Bleeding on Probing

  Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.

• Full-Mouth Mean Plaque Index

  Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics

Bolu, Central, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Central Study Contacts

Zeynep Akgul, DDS, PhD

CONTACT

05304253826; zeyneppakgulakgul@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 17, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)