GingivitisNCT07765251
Angiogenesis in Periodontal Disease
An observational study of Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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.
Who may be able to join
- presence of ≥ 20 teeth in the mouth
- probing pocket depth (PPD) ≤ 3 mm
- the percentage of bleeding sites for the whole mouth < 10%,
- on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 20 teeth in the mouth
- PPD ≤ 3 mm,
Show all 15Show fewer
- -% of bleeding sites for the whole mouth ≥ 10%,
- on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 15 teeth in the mouth
- more than 30% of teeth affected by periodontal disease
- affected teeth exhibiting probing depths of 6 mm or more
- clinical attachment loss (CAL) of ≥ 5 mm,
- vertical bone loss of 3 mm or more
- class 2 or 3 furcation involvement
- radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Who cannot join
- presence of any systemic disease
- regular use of any medication
- pregnancy or lactation
- periodontal treatment within the last 6 months
- antibiotic use within the last 6 months
- the presence of prosthetic restorations on the teeth to be sampled
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry, Deparment of Periodontology
Malatya, 44100
About this study
Official title: Smoking is Associated With Angiogenesis Through the Expression of FBXW7 and KLF2 in Periodontal Disease
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.
Read the detailed description
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.
- Conditions
- Gingivitis
- Keywords
- periodontitis, gingivitis, smoking, angiogenesis
- Medical subject headings
- Gingivitis, 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 |
|---|---|---|
| Group H | periodontally healthy and non smokers | |
| Group G | gingivitis and non-smokers | |
| Group P | periodontitis and non-smokers | |
| Group S-H | periodontally healthy and non smokers | |
| Group S-G | gingivitis and smokers | |
| Group S-P | periodontitis and non-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March to September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
- Investigators
- Kubra Aral, Phd, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765251
- Sponsor's protocol ID
- 2023-3374
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
PubMed 30536725Leite FRM, Nascimento GG, Scheutz F, Lopez R. Effect of Smoking on Periodontitis: A Systematic Review and Meta-regression. Am J Prev Med. 2018 Jun;54(6):831-841. doi: 10.1016/j.amepre.2018.02.014. Epub 2018 Apr 12.
PubMed 29656920Kawanami D, Mahabeleshwar GH, Lin Z, Atkins GB, Hamik A, Haldar SM, Maemura K, Lamanna JC, Jain MK. Kruppel-like factor 2 inhibits hypoxia-inducible factor 1alpha expression and function in the endothelium. J Biol Chem. 2009 Jul 31;284(31):20522-30. doi: 10.1074/jbc.M109.025346. Epub 2009 Jun 1.
PubMed 19491109Arabi A, Ullah K, Branca RM, Johansson J, Bandarra D, Haneklaus M, Fu J, Aries I, Nilsson P, Den Boer ML, Pokrovskaja K, Grander D, Xiao G, Rocha S, Lehtio J, Sangfelt O. Proteomic screen reveals Fbw7 as a modulator of the NF-kappaB pathway. Nat Commun. 2012;3:976. doi: 10.1038/ncomms1975.
PubMed 22864569
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking is Associated With Angiogenesis Through the Expression of FBXW7 and KLF2 in Periodontal Disease
- ClinicalTrials.gov ID
- NCT07765251
- Acronym / sponsor ID
- 2023-3374
- Conditions
- Gingivitis
- Keywords
- periodontitis, gingivitis, smoking, angiogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Aug 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group H | – | –periodontally healthy and non smokers |
| Group G | – | –gingivitis and non-smokers |
| Group P | – | –periodontitis and non-smokers |
| Group S-H | – | –periodontally healthy and non smokers |
| Group S-G | – | –gingivitis and smokers |
| Group S-P | – | –periodontitis and non-smokers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- presence of ≥ 20 teeth in the mouth
- probing pocket depth (PPD) ≤ 3 mm
- the percentage of bleeding sites for the whole mouth < 10%,
- on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
- presence of ≥ 20 teeth in the mouth
Key exclusion criteria (6 listed)
- presence of any systemic disease
- regular use of any medication
- pregnancy or lactation
- periodontal treatment within the last 6 months
- antibiotic use within the last 6 months
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
GCF and Salivary VEGF, NF-κB, KLF2, and FBXW7 Protein Levels
Time frame: March to September 2024
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 30536725Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
- Background: PubMed 29656920Leite FRM, Nascimento GG, Scheutz F, Lopez R. Effect of Smoking on Periodontitis: A Systematic Review and Meta-regression. Am J Prev Med. 2018 Jun;54(6):831-841. doi: 10.1016/j.amepre.2018.02.014. Epub 2018 Apr 12.
- Background: PubMed 19491109Kawanami D, Mahabeleshwar GH, Lin Z, Atkins GB, Hamik A, Haldar SM, Maemura K, Lamanna JC, Jain MK. Kruppel-like factor 2 inhibits hypoxia-inducible factor 1alpha expression and function in the endothelium. J Biol Chem. 2009 Jul 31;284(31):20522-30. doi: 10.1074/jbc.M109.025346. Epub 2009 Jun 1.
- Background: PubMed 22864569Arabi A, Ullah K, Branca RM, Johansson J, Bandarra D, Haneklaus M, Fu J, Aries I, Nilsson P, Den Boer ML, Pokrovskaja K, Grander D, Xiao G, Rocha S, Lehtio J, Sangfelt O. Proteomic screen reveals Fbw7 as a modulator of the NF-kappaB pathway. Nat Commun. 2012;3:976. doi: 10.1038/ncomms1975.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Kubra Aral, Phd study director
Inonu University
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 Gingivitis, run by Inonu 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 15 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCF and Salivary VEGF, NF-κB, KLF2, and FBXW7 Protein Levels (time frame: March to September 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07765251, which also lists 4 linked publications.
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 14 Aug 2026.