PeriodontitisNCT07758374
GFI-1 and Periodontal Disease
An observational study of Periodontitis and Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Gum disease, including gingivitis and its more advanced form, periodontitis, is a common condition that damages the tissues supporting the teeth. This study examines how gum disease affects the expression of specific genes and proteins that regulate communication between internal cell structures and the clearance of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, 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 60 participants (20 per group; 30 male, 30 female) were included.
Who may be able to join
- Inclusion criteria for the Healthy Control group were: presence of ≥ 20 teeth in the mouth, probing pocket depth (PPD) ≤ 3 mm, the percentage of bleeding sites for the whole mouth < 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Gingivitis group were: presence of ≥ 20 teeth in the mouth, PPD ≤ 3 mm, % of bleeding sites for the whole mouth ≥ 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Stage 3 Periodontitis group were: 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 and clinical attachment loss (CAL) of ≥ 5 mm, vertical bone loss of 3 mm or more, class 2 or 3 furcation involvement, and radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Who cannot join
- Exclusion criteria for all groups were defined as: presence of any systemic disease, regular use of any medication, smoking, pregnancy or lactation, periodontal treatment within the last 6 months, antibiotic use within the last 6 months, and the presence of prosthetic restorations on the teeth to be sampled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Involvement of GFI-1 in the Pathogenesis of Periodontal Disease
Gum disease, including gingivitis and its more advanced form, periodontitis, is a common condition that damages the tissues supporting the teeth. This study examines how gum disease affects the expression of specific genes and proteins that regulate communication between internal cell structures and the clearance of damaged material. Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already undergoing. These samples will be used to measure the expression levels of the GFI1, NF-κB, and NLRP3 genes/proteins, along with IL-1beta levels. In a separate laboratory experiment, gum cells will be exposed to a substance produced by bacteria commonly associated with gum disease, to observe how these same genes and protein respond. The goal of this study is to better understand the biological changes that occur in gum tissue as gum disease progresses, which may help guide future research into new treatments.
Read the detailed description
Periodontal disease encompasses a spectrum of inflammatory conditions, from gingivitis to more advanced periodontitis, that progressively damage the tooth-supporting tissues. Although its pathogenesis has been studied extensively, the molecular mechanisms driving the inflammatory response in periodontal tissues are not yet fully understood. Inflammasomes, multiprotein complexes known to regulate inflammatory processes, have been proposed to play a role in this pathogenesis, but the contribution of their regulatory proteins remains unclear. This study investigates the potential role of GFI-1, a regulator of inflammasome activity, in periodontal disease, along with its relationship to NLRP3, IL-1β, and NF-κB, structures known to be involved in inflammasome signaling and inflammatory regulation. The study consists of two complementary components. In the in vitro component, human gingival fibroblast cells will be stimulated with lipopolysaccharide (LPS) derived from Porphyromonas gingivalis and/or ATP to model bacterially driven inflammatory activation. Gene expression levels of GFI-1, NLRP3, IL-1β, and NF-κB will be measured using RT-PCR to characterize how these structures respond to bacterial and inflammatory stimuli. In the clinical component, gingival tissue samples will be collected from patients with periodontal disease as well as from periodontally healthy individuals during dental procedures they are already undergoing. Gene and protein expression levels of GFI-1, NLRP3, IL-1β, and NF-κB in these tissues will be assessed using RT-PCR and Western blotting, and IL-1β protein levels will additionally be quantified by ELISA. By comparing findings from the in vitro and clinical components, this study aims to determine whether GFI-1 is dysregulated at the gene and protein level in periodontal disease and to clarify its potential role in disease pathogenesis. These findings may contribute to a better understanding of the inflammatory mechanisms underlying periodontal disease and help inform future research into targeted therapeutic approaches.
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, inflammation, inflammasome
- Medical subject headings
- Periodontitis, Gingivitis, Inflammation
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 |
|---|---|---|
| periodontally healthy | periodontally healthy participants | |
| gingivitis | patients with gingivitis | |
| periodontitis | patients with periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFI1, NLRP3, NF-KB, IL-1beta Gene and Protein Expression
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of GFI1, NLRP3, NF-KB, IL-1beta were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis
Measured: January to July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 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 PeriodontitisStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758374
- Sponsor's protocol ID
- IU-CAP-TCD-2022-2717
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 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
Zhu L, Meng Q, Liang S, Ma Y, Li R, Li G, Zeng H. The transcription factor GFI1 negatively regulates NLRP3 inflammasome activation in macrophages. FEBS Lett. 2014 Nov 28;588(23):4513-9. doi: 10.1016/j.febslet.2014.10.025.
PubMed 25447538Hock H, Orkin SH. Zinc-finger transcription factor Gfi-1: versatile regulator of lymphocytes, neutrophils and hematopoietic stem cells. Curr Opin Hematol. 2006 Jan;13(1):1-6. doi: 10.1097/01.moh.0000190111.85284.8f.
PubMed 16319680Aral K, Berdeli E, Cooper PR, Milward MR, Kapila Y, Karadede Unal B, Aral CA, Berdeli A. Differential expression of inflammasome regulatory transcripts in periodontal disease. J Periodontol. 2020 May;91(5):606-616. doi: 10.1002/JPER.19-0222. Epub 2019 Oct 17.
PubMed 31557327Aral K, Milward MR, Kapila Y, Berdeli A, Cooper PR. Inflammasomes and their regulation in periodontal disease: A review. J Periodontal Res. 2020 Aug;55(4):473-487. doi: 10.1111/jre.12733. Epub 2020 Jan 20.
PubMed 31960443
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Involvement of GFI-1 in the Pathogenesis of Periodontal Disease
- ClinicalTrials.gov ID
- NCT07758374
- Acronym / sponsor ID
- IU-CAP-TCD-2022-2717
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, inflammation, inflammasome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 11 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, including gingivitis and its more advanced form, periodontitis, is a common condition that damages the tissues supporting the teeth. This study examines how gum disease affects the expression of specific genes and proteins that regulate communication between internal cell structures and the clearance of damaged material. Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already undergoing. These samples will be used to measure the expression levels of the GFI1, NF-κB, and NLRP3 genes/proteins, along with IL-1beta levels. In a separate laboratory experiment, gum cells will be exposed to a substance produced by bacteria commonly associated with gum disease, to observe how these same genes and protein respond. The goal of this study is to better understand the biological changes that occur in gum tissue as gum disease progresses, which may help guide future research into new treatments.
Detailed description
Periodontal disease encompasses a spectrum of inflammatory conditions, from gingivitis to more advanced periodontitis, that progressively damage the tooth-supporting tissues. Although its pathogenesis has been studied extensively, the molecular mechanisms driving the inflammatory response in periodontal tissues are not yet fully understood. Inflammasomes, multiprotein complexes known to regulate inflammatory processes, have been proposed to play a role in this pathogenesis, but the contribution of their regulatory proteins remains unclear. This study investigates the potential role of GFI-1, a regulator of inflammasome activity, in periodontal disease, along with its relationship to NLRP3, IL-1β, and NF-κB, structures known to be involved in inflammasome signaling and inflammatory regulation. The study consists of two complementary components. In the in vitro component, human gingival fibroblast cells will be stimulated with lipopolysaccharide (LPS) derived from Porphyromonas gingivalis and/or ATP to model bacterially driven inflammatory activation. Gene expression levels of GFI-1, NLRP3, IL-1β, and NF-κB will be measured using RT-PCR to characterize how these structures respond to bacterial and inflammatory stimuli. In the clinical component, gingival tissue samples will be collected from patients with periodontal disease as well as from periodontally healthy individuals during dental procedures they are already undergoing. Gene and protein expression levels of GFI-1, NLRP3, IL-1β, and NF-κB in these tissues will be assessed using RT-PCR and Western blotting, and IL-1β protein levels will additionally be quantified by ELISA. By comparing findings from the in vitro and clinical components, this study aims to determine whether GFI-1 is dysregulated at the gene and protein level in periodontal disease and to clarify its potential role in disease pathogenesis. These findings may contribute to a better understanding of the inflammatory mechanisms underlying periodontal disease and help inform future research into targeted therapeutic approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy | – | –periodontally healthy participants |
| gingivitis | – | –patients with gingivitis |
| periodontitis | – | –patients with periodontitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, 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 60 participants (20 per group; 30 male, 30 female) were included.
Key inclusion criteria (1 listed)
- Inclusion criteria for the Healthy Control group were: presence of ≥ 20 teeth in the mouth, probing pocket depth (PPD) ≤ 3 mm, the percentage of bleeding sites for the whole mouth < 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Gingivitis group were: presence of ≥ 20 teeth in the mouth, PPD ≤ 3 mm, % of bleeding sites for the whole mouth ≥ 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Stage 3 Periodontitis group were: 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 and clinical attachment loss (CAL) of ≥ 5 mm, vertical bone loss of 3 mm or more, class 2 or 3 furcation involvement, and radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Key exclusion criteria (1 listed)
- Exclusion criteria for all groups were defined as: presence of any systemic disease, regular use of any medication, smoking, pregnancy or lactation, periodontal treatment within the last 6 months, antibiotic use within the last 6 months, and the presence of prosthetic restorations on the teeth to be sampled
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
GFI1, NLRP3, NF-KB, IL-1beta Gene and Protein Expression
Time frame: January to July 2024
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of GFI1, NLRP3, NF-KB, IL-1beta were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis
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 11 Aug 2026.
- Background: PubMed 25447538Zhu L, Meng Q, Liang S, Ma Y, Li R, Li G, Zeng H. The transcription factor GFI1 negatively regulates NLRP3 inflammasome activation in macrophages. FEBS Lett. 2014 Nov 28;588(23):4513-9. doi: 10.1016/j.febslet.2014.10.025.
- Background: PubMed 16319680Hock H, Orkin SH. Zinc-finger transcription factor Gfi-1: versatile regulator of lymphocytes, neutrophils and hematopoietic stem cells. Curr Opin Hematol. 2006 Jan;13(1):1-6. doi: 10.1097/01.moh.0000190111.85284.8f.
- Background: PubMed 31557327Aral K, Berdeli E, Cooper PR, Milward MR, Kapila Y, Karadede Unal B, Aral CA, Berdeli A. Differential expression of inflammasome regulatory transcripts in periodontal disease. J Periodontol. 2020 May;91(5):606-616. doi: 10.1002/JPER.19-0222. Epub 2019 Oct 17.
- Background: PubMed 31960443Aral K, Milward MR, Kapila Y, Berdeli A, Cooper PR. Inflammasomes and their regulation in periodontal disease: A review. J Periodontal Res. 2020 Aug;55(4):473-487. doi: 10.1111/jre.12733. Epub 2020 Jan 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis and 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 1 inclusion and 1 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 11 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?
GFI1, NLRP3, NF-KB, IL-1beta Gene and Protein Expression (time frame: January to July 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 NCT07758374, 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 11 Aug 2026.