PeriodontitisNCT07751393
Signal-Transducing Adaptor Proteins in Periodontal Disease
An observational study of Periodontitis and Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study will look at certain proteins in the gums, saliva, and gum fluid of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Dec 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 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 75 participants (25 per group; 38 male, 37 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.
Turkey (Türkiye)1 site
Kubra Aral , Phd Ext. 422 341 01 06 kubra.aral@inonu.edu.tr
Malatya, 44100
About this study
Official title: Investigation of the Role of Signal-Transducing Adaptor Proteins in Periodontal Disease
This study will look at certain proteins in the gums, saliva, and gum fluid of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied called STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3, are known to be involved in inflammation and cell health in other diseases, but their role in gum disease is not well understood. Seventy-five healthy adults will be grouped by their gum health status. Samples of saliva and gum fluid will be collected and tested, and gum tissue samples will be collected from a subset of participants during routine dental treatment. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease. The results are expected to show whether these proteins are found at different levels in people with periodontitis compared to those with healthy gums, suggesting they may play a role in how gum disease develops and progresses. This information may help researchers better understand the biological processes behind periodontal disease and could eventually contribute to new ways of detecting or treating it.
Read the detailed description
Signal-transducing adaptor proteins (STAPs), particularly STAP-1 and STAP-2, are involved in intracellular signaling pathways that regulate cell growth, immune responses, and inflammatory processes, and have been implicated in the pathogenesis of several chronic inflammatory and malignant conditions. Their regulatory partners, STAT3 and STAT5A, are transcription factors known to modulate immune and inflammatory signaling, while NLRP3 (a key component of the inflammasome) and CASP3 (a central mediator of apoptosis) are closely linked to tissue destruction and programmed cell death in chronic inflammatory diseases. Although periodontal disease is fundamentally driven by a dysregulated host inflammatory and immune response to bacterial biofilm, the involvement of STAP-1, STAP-2, and their associated signaling molecules in this process has not previously been investigated. This study will enroll 75 systemically healthy adults, allocated into three groups of 25 participants each based on periodontal status: periodontally healthy, gingivitis, and periodontitis. Diagnosis and group allocation will be based on standard clinical periodontal parameters. From all 75 participants, gingival crevicular fluid (GCF) and unstimulated whole saliva samples will be collected. In addition, gingival tissue biopsies will be obtained from a subset of 60 systemically healthy participants (20 per group), collected during periodontal or extraction procedures that are independently clinically indicated. GCF and saliva samples will be analyzed for total levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3 using enzyme-linked immunosorbent assay (ELISA). Gingival tissue samples will be analyzed for relative gene expression of the same six molecules using real-time quantitative polymerase chain reaction (RT-qPCR). Clinical periodontal parameters (such as probing depth, clinical attachment level, bleeding on probing, and plaque index) will be recorded for all participants at the time of sampling. Statistical analyses will compare protein and gene expression levels across the three periodontal groups and will assess correlations among STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3, as well as their relationships with clinical periodontal parameters, within GCF, saliva, and gingival tissue. The study aims to determine whether STAP family proteins and their related inflammatory/apoptotic signaling molecules are differentially expressed according to periodontal disease severity, and whether they may serve as biological indicators involved in the inflammatory and tissue-destructive processes underlying periodontitis.
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, STAP family, inflammation, GCF
- 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.
GCF, saliva and Gingival levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method)levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 were measured in gingiva of participants. Protein levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 in GCF and saliva were measured by ELISA in study participants.
Measured: From may to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 May 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 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.
- 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
- 75 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
- NCT07751393
- Sponsor's protocol ID
- IU-2024-3795
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 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
Aral K, Aral CA, Kapila Y. The role of caspase-8, caspase-9, and apoptosis inducing factor in periodontal disease. J Periodontol. 2019 Mar;90(3):288-294. doi: 10.1002/JPER.17-0716. Epub 2018 Oct 26.
PubMed 30311940Aral 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 31960443Luo L, Wang F, Xu X, Ma M, Kuang G, Zhang Y, Wang D, Li W, Zhang N, Zhao K. STAT3 promotes NLRP3 inflammasome activation by mediating NLRP3 mitochondrial translocation. Exp Mol Med. 2024 Sep;56(9):1980-1990. doi: 10.1038/s12276-024-01298-9. Epub 2024 Sep 2.
PubMed 39218978Kashiwakura JI, Oritani K, Matsuda T. The Functional Properties and Physiological Roles of Signal-Transducing Adaptor Protein-2 in the Pathogenesis of Inflammatory and Immune Disorders. Biomedicines. 2022 Nov 30;10(12):3079. doi: 10.3390/biomedicines10123079.
PubMed 36551835
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of Signal-Transducing Adaptor Proteins in Periodontal Disease
- ClinicalTrials.gov ID
- NCT07751393
- Acronym / sponsor ID
- IU-2024-3795
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, STAP family, inflammation, GCF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 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.
This study will look at certain proteins in the gums, saliva, and gum fluid of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied called STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3, are known to be involved in inflammation and cell health in other diseases, but their role in gum disease is not well understood. Seventy-five healthy adults will be grouped by their gum health status. Samples of saliva and gum fluid will be collected and tested, and gum tissue samples will be collected from a subset of participants during routine dental treatment. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease. The results are expected to show whether these proteins are found at different levels in people with periodontitis compared to those with healthy gums, suggesting they may play a role in how gum disease develops and progresses. This information may help researchers better understand the biological processes behind periodontal disease and could eventually contribute to new ways of detecting or treating it.
Detailed description
Signal-transducing adaptor proteins (STAPs), particularly STAP-1 and STAP-2, are involved in intracellular signaling pathways that regulate cell growth, immune responses, and inflammatory processes, and have been implicated in the pathogenesis of several chronic inflammatory and malignant conditions. Their regulatory partners, STAT3 and STAT5A, are transcription factors known to modulate immune and inflammatory signaling, while NLRP3 (a key component of the inflammasome) and CASP3 (a central mediator of apoptosis) are closely linked to tissue destruction and programmed cell death in chronic inflammatory diseases. Although periodontal disease is fundamentally driven by a dysregulated host inflammatory and immune response to bacterial biofilm, the involvement of STAP-1, STAP-2, and their associated signaling molecules in this process has not previously been investigated. This study will enroll 75 systemically healthy adults, allocated into three groups of 25 participants each based on periodontal status: periodontally healthy, gingivitis, and periodontitis. Diagnosis and group allocation will be based on standard clinical periodontal parameters. From all 75 participants, gingival crevicular fluid (GCF) and unstimulated whole saliva samples will be collected. In addition, gingival tissue biopsies will be obtained from a subset of 60 systemically healthy participants (20 per group), collected during periodontal or extraction procedures that are independently clinically indicated. GCF and saliva samples will be analyzed for total levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3 using enzyme-linked immunosorbent assay (ELISA). Gingival tissue samples will be analyzed for relative gene expression of the same six molecules using real-time quantitative polymerase chain reaction (RT-qPCR). Clinical periodontal parameters (such as probing depth, clinical attachment level, bleeding on probing, and plaque index) will be recorded for all participants at the time of sampling. Statistical analyses will compare protein and gene expression levels across the three periodontal groups and will assess correlations among STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3, as well as their relationships with clinical periodontal parameters, within GCF, saliva, and gingival tissue. The study aims to determine whether STAP family proteins and their related inflammatory/apoptotic signaling molecules are differentially expressed according to periodontal disease severity, and whether they may serve as biological indicators involved in the inflammatory and tissue-destructive processes underlying periodontitis.
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 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 75 participants (25 per group; 38 male, 37 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
GCF, saliva and Gingival levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3
Time frame: From may to December 2024
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method)levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 were measured in gingiva of participants. Protein levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 in GCF and saliva were measured by ELISA in study participants.
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 7 Aug 2026.
- Background: PubMed 30311940Aral K, Aral CA, Kapila Y. The role of caspase-8, caspase-9, and apoptosis inducing factor in periodontal disease. J Periodontol. 2019 Mar;90(3):288-294. doi: 10.1002/JPER.17-0716. Epub 2018 Oct 26.
- 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.
- Background: PubMed 39218978Luo L, Wang F, Xu X, Ma M, Kuang G, Zhang Y, Wang D, Li W, Zhang N, Zhao K. STAT3 promotes NLRP3 inflammasome activation by mediating NLRP3 mitochondrial translocation. Exp Mol Med. 2024 Sep;56(9):1980-1990. doi: 10.1038/s12276-024-01298-9. Epub 2024 Sep 2.
- Background: PubMed 36551835Kashiwakura JI, Oritani K, Matsuda T. The Functional Properties and Physiological Roles of Signal-Transducing Adaptor Protein-2 in the Pathogenesis of Inflammatory and Immune Disorders. Biomedicines. 2022 Nov 30;10(12):3079. doi: 10.3390/biomedicines10123079.
- 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 7 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, saliva and Gingival levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 (time frame: From may to December 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 NCT07751393, 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 7 Aug 2026.