SMOKING AND GINGIVAL CREVICULAR FLUID MFN1 AND NLRP3 LEVELS IN PERIODONTAL HEALTH AND PERIODONTITIS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAbant Izzet Baysal University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
ormer cigarette smoking. Use of electronic cigarettes, heated tobacco products, nicotine pouches, or nicotine replacement products.
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
88 Participants
are grouped into 4 trial groupsGroup A: Periodontally Healthy Nonsmokers
Group B: Periodontally Healthy Smokers
Group C: Nonsmokers With Periodontitis
Group D: Smokers With Periodontitis
Trial outcomes
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.
Time frame
Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.Secondary outcomes
1
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.
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 periodonti2
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.
Time frame
Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.3
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.
Time frame
Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.4
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.
Time frame
Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov