PeriodontitisSTAT3EpPPiNCT07055256
Elucidating the Role of STAT3 in Epithelial-microbiome Interaction During Periodontitis and Peri-implantitis
An observational study of Periodontitis and Peri-implantitis, run by University of Chile at 1 site in Chile.
Trial summary
Periodontitis and peri-implantitis are highly prevalent immuno-inflammatory pathologies, characterized by a series of intracellular signals, which, as a consequence of the interaction of the gingival epithelium with the dysbiotic microbiome, lead to an exacerbated immuno-inflammatory response, ultimately resulting in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Peri-implantitis
- How many people
- 43 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2023to 30 Jan 2025
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects over 17 years of age who attend the Dental Clinic of the Faculty of Dentistry of the University of Chile and present with a diagnosis of gingival health, periodontitis, and peri-implantitis, according to the classification of periodontal and peri-implant diseases (Caton et al., 2018), will be recruited and examined. All subjects must sign an informed consent form previously validated by an ethics committee and meet the inclusion and exclusion criteria.
Who may be able to join
- Patients in the gingival health group:
- Meet the case definition of gingival health (Chapple et al. 2018).
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
- Patients in the periodontitis group:
- Meet the case definition of periodontitis (Papapanou et al. 2018).
Show all 12Show fewer
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
- Patients in the peri-implantitis group:
- Meet the case definition of periodontitis and peri-implantitis (Berglundh et al., 2018).
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect a microbiological sample for the study.
Who cannot join
- 1. Having used systemic antibiotics (intravenous, intramuscular, or oral) in the last six months.
- 2. Having used corticosteroids or other immunosuppressants (e.g., cyclosporine), cytokine therapy, methotrexate, or any other immunosuppressive chemical agent, or high-dose commercially available probiotics (≥ 108 colony-forming units per day) in tablet, capsule, or powder form within the last three months. The use of fermented foods/liquids, e.g., milk, yogurt, etc., does not apply to the exclusion of the individual.
- 3. Being pregnant or breastfeeding. 4. Subjects who cannot give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis and peri-implantitis are highly prevalent immuno-inflammatory pathologies, characterized by a series of intracellular signals, which, as a consequence of the interaction of the gingival epithelium with the dysbiotic microbiome, lead to an exacerbated immuno-inflammatory response, ultimately resulting in tissue loss around teeth and implants. STAT3 is a transcription factor that plays a key role in inflammatory diseases, which when phosphorylated (pSTAT3) promotes the transcription of genes with immuno-defensive functions. STAT3 phosphorylation has only been reported during experimental periodontitis, but our preliminary results reveal a higher number of epithelial cells with the presence of pSTAT3 in subjects with periodontitis. Other studies have reported greater STAT3 activation in oral keratinocyte cells stimulated with LPS from P. gingivalis, which and F. nucleatum are abundant bacterial species in both pathologies. On the other hand, inhibition of the STAT3 pathway is a therapeutic target in multiple inflammatory diseases, where inhibitors such as C188-9 have shown a direct effect on STAT3 signaling. A better understanding of this signaling pathway in periodontitis and peri-implantitis could allow for future complementary therapies for these diseases.
Based on the above, the hypothesis of this project is:
Read more
"During periodontitis and peri-implantitis, there is greater activation of STAT3, particularly at the level of the gingival epithelium, inducing an increase in immune-defensive function in response to microbial dysbiosis and specific constituents of the microbiota associated with these pathologies compared to gingival health."
General objective: To evaluate STAT3 activation and its immune-defensive function during gingival health, periodontitis, and peri-implantitis, specifically at the level of the gingival epithelium, in response to microbial dysbiosis and specific bacteria associated with these periodontal conditions.
Objective 1: To characterize STAT3 activation and immune-defensive function in gingival tissue during gingival health, periodontitis, and peri-implantitis. The investigators will obtain gingival tissue samples from the three conditions through a clinical study. These samples will be processed by Western blot and immunofluorescence to determine pSTAT3. In addition, RT-qPCR will determine the expression of genes related to its immune-defensive function.
Objective 2: To determine STAT3 activation and its immune-defensive function in oral keratinocytes in response to the subgingival biofilm associated with gingival health, periodontitis, and peri-implantitis: Subgingival microbiota samples will be obtained from the three conditions, and the microbiome related to each condition will be characterized by massive sequencing of the 16S rDNA gene. Furthermore, through an in vitro study, oral keratinocyte cells will be stimulated with the obtained samples, and the expression of genes related to their immune-defense function will be determined by Western blot, pSTAT3, and RT-qPCR. The effect of STAT3 inhibition using C188-9 will be subsequently evaluated.
Objective 3: Determine STAT3 activation and its immune-defense function in oral keratinocytes in response to specific bacteria associated with gingival health, periodontitis, and peri-implantitis. Through an in vitro study, oral keratinocyte cells will be infected with reference strains of S. sanguinis, P. gingivalis, and F. nucleatum, and the expression of genes related to their immune-defense function will be determined by Western blot, pSTAT3, and RT-qPCR.
The investigators hope to achieve greater activation of STAT3 and increased expression of genes related to the immune-defensive response of the gingival epithelium during periodontitis and peri-implantitis. The investigators also hope to determine the effect of STAT3 inhibition, expecting a reduction in the expression of genes related to this response.
Read the detailed description
Aim: To characterize STAT3 activation and immune defense function in gingival tissue during gingival health, periodontitis, and peri-implantitis.
Subject Selection:
This study will comply with the Declaration of Helsinki (October 2013) and Chilean legal and regulatory requirements. The study will be conducted at the Dental Clinic of the Faculty of Dentistry of the University of Chile.
Subjects attending the Dental Clinic of the Faculty of Dentistry of the University of Chile and diagnosed with gingival health, periodontitis, and peri-implantitis, according to the classification of periodontal and peri-implant diseases, will be recruited and examined.
All subjects must sign an informed consent form previously validated by an ethics committee and meet the following inclusion and exclusion criteria:
Inclusion Criteria:
Patients in the Gingival Health Group:
- Meet the case definition of gingival health.
- ≥18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
Patients in the Periodontitis Group:
- Meet the case definition of periodontitis.
- ≥18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
Patients in the Peri-Implantitis Group:
- Meet the case definition of periodontitis and peri-implantitis.
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect a microbiological sample for the study.
Exclusion criteria:
- Using systemic antibiotics (intravenous, intramuscular, or oral) in the last six months.
- Having used corticosteroids or other immunosuppressants (e.g., cyclosporine), cytokine therapy, methotrexate or any other immunosuppressive chemical agent, or high-dose commercially available probiotics (≥ 108 colony-forming units per day) in tablet, capsule, or powder form in the last three months. The use of fermented foods/liquids, e.g., milk, yogurt, etc., does not apply to the exclusion of the individual.
- Being pregnant or breastfeeding.
- Subjects who cannot give consent.
Intraoral Examination: All subjects will undergo a full-mouth examination using a specially designed form (Appendix 3). General history (age, biological sex, occupation), habits, diseases, and medications will be recorded. A periodontogram will also be included to record periodontal measurements, probing depths, clinical attachment loss, bleeding on probing, etc.
Sample Collection: Representative gingival collar biopsies (2 mm wide) will be collected under local anesthesia and placed in 4% formalin for histological analysis, T-PER (Thermofisher Scientific) for Western blot analysis, and RNA later (Thermofisher Scientific) for RT-qPCR analysis. In healthy subjects, these samples will be collected as biological waste and may be obtained, for example, in the following cases: crown lengthening surgeries, third molar extractions, or teeth where there is no significant risk of removing gingival tissue, molar areas with opercula, or gingiva covering part of the dental crown where removing gingival tissue is not a risk. In subjects with periodontitis and peri-implantitis, these samples will be collected during procedures before subgingival instrumentation and/or periodontal or peri-implant surgery in the most affected area at probing depths.
- STAT3 activation in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples stored in T-PER, protein extraction will be performed, and total STAT3 and its activation (pSTAT3) will be determined using Western blot using antibodies that recognize STAT3 and pSTAT3 at Tyr705 (Cell Signaling Technology, USA). GAPDH will be used as a loading control, and the bands obtained will be quantified using ImageJ software (NIH, Bethesda, USA).
- Characterization of pSTAT3 in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples fixed in 4% formalin, the localization of pSTAT3 (epithelium and connective tissue) will be determined using immunofluorescence using antibodies that recognize CD45 for immune cells, Ck5 for epithelial cells, and pSTAT3 for the activated protein. The co-localization of pSTAT3-Ck5 and pSTAT3-CD45 will be determined by confocal microscopy at 40x.
- Analysis of the pSTAT3-mediated immune-defense response in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples stored in RNA later, total RNA will be extracted, and the following genes associated with the immune-defense response will be amplified using the RT-qPCR technique:
- Conditions
- Periodontitis, Peri-implantitis
- Keywords
- Periodontitis, Peri-implantitis, STAT3, Epithellial cells
- Medical subject headings
- Periodontitis, Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of epithelial cells that present activated STAT3 protein
Measured as a percentage of epithelial cells that present the activated protein from 0 to 100, where 0 means no epithelial cells activate the protein, and 100% means all cells present it.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jun 2023
- Primary completion10 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055256
- Sponsor's protocol ID
- 2023/07
- Other IDs
- 1231350, 1231728, 21221003, 22-004, 22/385
- Acronym
- STAT3EpPPi
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of STAT3 in Epithelial-microbiome Interaction During Periodontitis and Peri-implantitis
- ClinicalTrials.gov ID
- NCT07055256
- Acronym / sponsor ID
- STAT3EpPPi / 2023/07
- Conditions
- Periodontitis, Peri-implantitis
- Keywords
- Periodontitis, Peri-implantitis, STAT3, Epithellial cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 8 Jul 2025 (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.
Periodontitis and peri-implantitis are highly prevalent immuno-inflammatory pathologies, characterized by a series of intracellular signals, which, as a consequence of the interaction of the gingival epithelium with the dysbiotic microbiome, lead to an exacerbated immuno-inflammatory response, ultimately resulting in tissue loss around teeth and implants. STAT3 is a transcription factor that plays a key role in inflammatory diseases, which when phosphorylated (pSTAT3) promotes the transcription of genes with immuno-defensive functions. STAT3 phosphorylation has only been reported during experimental periodontitis, but our preliminary results reveal a higher number of epithelial cells with the presence of pSTAT3 in subjects with periodontitis. Other studies have reported greater STAT3 activation in oral keratinocyte cells stimulated with LPS from P. gingivalis, which and F. nucleatum are abundant bacterial species in both pathologies. On the other hand, inhibition of the STAT3 pathway is a therapeutic target in multiple inflammatory diseases, where inhibitors such as C188-9 have shown a direct effect on STAT3 signaling. A better understanding of this signaling pathway in periodontitis and peri-implantitis could allow for future complementary therapies for these diseases.
Based on the above, the hypothesis of this project is:
"During periodontitis and peri-implantitis, there is greater activation of STAT3, particularly at the level of the gingival epithelium, inducing an increase in immune-defensive function in response to microbial dysbiosis and specific constituents of the microbiota associated with these pathologies compared to gingival health."
General objective: To evaluate STAT3 activation and its immune-defensive function during gingival health, periodontitis, and peri-implantitis, specifically at the level of the gingival epithelium, in response to microbial dysbiosis and specific bacteria associated with these periodontal conditions.
Objective 1: To characterize STAT3 activation and immune-defensive function in gingival tissue during gingival health, periodontitis, and peri-implantitis. The investigators will obtain gingival tissue samples from the three conditions through a clinical study. These samples will be processed by Western blot and immunofluorescence to determine pSTAT3. In addition, RT-qPCR will determine the expression of genes related to its immune-defensive function.
Objective 2: To determine STAT3 activation and its immune-defensive function in oral keratinocytes in response to the subgingival biofilm associated with gingival health, periodontitis, and peri-implantitis: Subgingival microbiota samples will be obtained from the three conditions, and the microbiome related to each condition will be characterized by massive sequencing of the 16S rDNA gene. Furthermore, through an in vitro study, oral keratinocyte cells will be stimulated with the obtained samples, and the expression of genes related to their immune-defense function will be determined by Western blot, pSTAT3, and RT-qPCR. The effect of STAT3 inhibition using C188-9 will be subsequently evaluated.
Objective 3: Determine STAT3 activation and its immune-defense function in oral keratinocytes in response to specific bacteria associated with gingival health, periodontitis, and peri-implantitis. Through an in vitro study, oral keratinocyte cells will be infected with reference strains of S. sanguinis, P. gingivalis, and F. nucleatum, and the expression of genes related to their immune-defense function will be determined by Western blot, pSTAT3, and RT-qPCR.
The investigators hope to achieve greater activation of STAT3 and increased expression of genes related to the immune-defensive response of the gingival epithelium during periodontitis and peri-implantitis. The investigators also hope to determine the effect of STAT3 inhibition, expecting a reduction in the expression of genes related to this response.
Detailed description
Aim: To characterize STAT3 activation and immune defense function in gingival tissue during gingival health, periodontitis, and peri-implantitis.
Subject Selection:
This study will comply with the Declaration of Helsinki (October 2013) and Chilean legal and regulatory requirements. The study will be conducted at the Dental Clinic of the Faculty of Dentistry of the University of Chile.
Subjects attending the Dental Clinic of the Faculty of Dentistry of the University of Chile and diagnosed with gingival health, periodontitis, and peri-implantitis, according to the classification of periodontal and peri-implant diseases, will be recruited and examined.
All subjects must sign an informed consent form previously validated by an ethics committee and meet the following inclusion and exclusion criteria:
Inclusion Criteria:
Patients in the Gingival Health Group:
- Meet the case definition of gingival health.
- ≥18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
Patients in the Periodontitis Group:
- Meet the case definition of periodontitis.
- ≥18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
Patients in the Peri-Implantitis Group:
- Meet the case definition of periodontitis and peri-implantitis.
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect a microbiological sample for the study.
Exclusion criteria:
- Using systemic antibiotics (intravenous, intramuscular, or oral) in the last six months.
- Having used corticosteroids or other immunosuppressants (e.g., cyclosporine), cytokine therapy, methotrexate or any other immunosuppressive chemical agent, or high-dose commercially available probiotics (≥ 108 colony-forming units per day) in tablet, capsule, or powder form in the last three months. The use of fermented foods/liquids, e.g., milk, yogurt, etc., does not apply to the exclusion of the individual.
- Being pregnant or breastfeeding.
- Subjects who cannot give consent.
Intraoral Examination: All subjects will undergo a full-mouth examination using a specially designed form (Appendix 3). General history (age, biological sex, occupation), habits, diseases, and medications will be recorded. A periodontogram will also be included to record periodontal measurements, probing depths, clinical attachment loss, bleeding on probing, etc.
Sample Collection: Representative gingival collar biopsies (2 mm wide) will be collected under local anesthesia and placed in 4% formalin for histological analysis, T-PER (Thermofisher Scientific) for Western blot analysis, and RNA later (Thermofisher Scientific) for RT-qPCR analysis. In healthy subjects, these samples will be collected as biological waste and may be obtained, for example, in the following cases: crown lengthening surgeries, third molar extractions, or teeth where there is no significant risk of removing gingival tissue, molar areas with opercula, or gingiva covering part of the dental crown where removing gingival tissue is not a risk. In subjects with periodontitis and peri-implantitis, these samples will be collected during procedures before subgingival instrumentation and/or periodontal or peri-implant surgery in the most affected area at probing depths.
- STAT3 activation in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples stored in T-PER, protein extraction will be performed, and total STAT3 and its activation (pSTAT3) will be determined using Western blot using antibodies that recognize STAT3 and pSTAT3 at Tyr705 (Cell Signaling Technology, USA). GAPDH will be used as a loading control, and the bands obtained will be quantified using ImageJ software (NIH, Bethesda, USA).
- Characterization of pSTAT3 in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples fixed in 4% formalin, the localization of pSTAT3 (epithelium and connective tissue) will be determined using immunofluorescence using antibodies that recognize CD45 for immune cells, Ck5 for epithelial cells, and pSTAT3 for the activated protein. The co-localization of pSTAT3-Ck5 and pSTAT3-CD45 will be determined by confocal microscopy at 40x.
- Analysis of the pSTAT3-mediated immune-defense response in gingival tissue during gingival health, periodontitis, and peri-implantitis: For samples stored in RNA later, total RNA will be extracted, and the following genes associated with the immune-defense response will be amplified using the RT-qPCR technique:
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 17 years of age who attend the Dental Clinic of the Faculty of Dentistry of the University of Chile and present with a diagnosis of gingival health, periodontitis, and peri-implantitis, according to the classification of periodontal and peri-implant diseases (Caton et al., 2018), will be recruited and examined. All subjects must sign an informed consent form previously validated by an ethics committee and meet the inclusion and exclusion criteria.
Key inclusion criteria (12 listed)
- Meet the case definition of gingival health (Chapple et al. 2018).
- ≥ 18 years of age.
- Willingness to donate gingival tissue and collect microbiological samples for the study.
- Meet the case definition of periodontitis (Papapanou et al. 2018).
- ≥ 18 years of age.
Key exclusion criteria (3 listed)
- 1. Having used systemic antibiotics (intravenous, intramuscular, or oral) in the last six months.
- 2. Having used corticosteroids or other immunosuppressants (e.g., cyclosporine), cytokine therapy, methotrexate, or any other immunosuppressive chemical agent, or high-dose commercially available probiotics (≥ 108 colony-forming units per day) in tablet, capsule, or powder form within the last three months. The use of fermented foods/liquids, e.g., milk, yogurt, etc., does not apply to the exclusion of the individual.
- 3. Being pregnant or breastfeeding. 4. Subjects who cannot give consent.
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
Percentage of epithelial cells that present activated STAT3 protein
Time frame: Baseline
Measured as a percentage of epithelial cells that present the activated protein from 0 to 100, where 0 means no epithelial cells activate the protein, and 100% means all cells present it.
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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 Peri-implantitis, run by University of Chile at 1 site in Chile.
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 12 inclusion and 3 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 8 Jul 2025. 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 Chile. 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?
Percentage of epithelial cells that present activated STAT3 protein (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025.