An observational study in Gingivitis, sponsored by Inonu University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Inonu University · Observational
Gum disease (gingivitis and periodontitis) is a common inflammatory condition affecting the tissues that support the teeth. Smoking is known to make gum disease worse and to affect blood vessel health in the gums. This study looks at two proteins, KLF2 and FBXW7, which are involved in blood vessel formation, to understand their role in gum disease and whether smoking changes their levels. Researchers measured these proteins, along with two other markers of inflammation and blood vessel activity (VEGF and NF-κB), in fluid collected from around the teeth and in saliva from healthy adults who were either smokers or non-smokers, with healthy gums, gingivitis, or periodontitis. The goal is to better understand how smoking and gum disease affect blood vessel-related proteins in the mouth.
Angiogenesis, the formation of new blood vessels, is considered an early host response involved in the progression of periodontal disease. KLF2 is a transcription factor that negatively regulates angiogenesis and endothelial activation, while FBXW7 contributes to vascular development and has been reported to modulate KLF2 expression. Smoking is a major modifiable risk factor for periodontal disease and is known to affect periodontal vascularity, although the underlying molecular mechanisms remain incompletely understood. This study evaluates the potential involvement of KLF2 and FBXW7, alongside the established angiogenic and inflammatory mediators VEGF and NF-κB, in periodontal disease pathogenesis, and examines whether smoking modifies their expression in gingival crevicular fluid and saliva.
Adults aged 18 to 65 years attending the periodontology clinic were enrolled and classified into 6 groups based on clinical periodontal parameters and smoking status according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III Grade B). Exclusion criteria included any systemic disease, regular medication use, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 114 participants (19 per group; 56 males, 58 females) were included.
Inclusion Criteria:
Inclusion criteria for the Healthy Control group:
Inclusion criteria for the Gingivitis group were
PPD ≤ 3 mm,
-% of bleeding sites for the whole mouth ≥ 10%,
Inclusion criteria for the Stage 3 Periodontitis group
Exclusion Criteria:
periodontally healthy and non smokers
gingivitis and non-smokers
periodontitis and non-smokers
periodontally healthy and non smokers
gingivitis and smokers
periodontitis and non-smokers
GCF and Salivary VEGF, NF-κB, KLF2, and FBXW7 Protein Levels
Total amounts and concentrations of VEGF, NF-κB, KLF2, and FBXW7 were measured by ELISA in gingival crevicular fluid (GCF) and unstimulated whole saliva samples, and compared across participants with periodontal health, gingivitis, and periodontitis, in both smokers and non-smokers.
Time frame: March to September 2024
Plan to share: Yes — De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing). Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Inonu University