Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07826728

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Periodontitis Behavior Mouth Diseases Periodontal Diseases Smoking Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bolu, Central, 14100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Zeynep Akgul

CONTACT

05304253826

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Full-Mouth Mean Probing Depth

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

    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.

  3. Full-Mouth Mean Clinical Attachment Level

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

    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.

  4. Percentage of Sites With Bleeding on Probing

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

    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.

  5. Full-Mouth Mean Plaque Index

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

    Full-Mouth Mean Plaque Index

  6. Full-Mouth Mean Gingival Index

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Akgul, DDS, PhD

CONTACT

[email protected]

05304253826

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

ASSOCİATİON BETWEEN SMOKİNG AND GİNGİVAL CREVİCULAR FLUİD MFN1 AND NLRP3 LEVELS İN INDİVİDUALS WİTH PERİODONTAL HEALTH OR PERİODONTİTİS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.