Last reviewed · How we verify
NCT07055256: STAT3EpPPi
Elucidating the Role of STAT3 in Epithelial-microbiome Interaction During Periodontitis and Peri-implantitis
trial in Periodontitis in 43 participants. Completed in 30 January 2025.
10 January 2025
Quick facts
| Lead sponsor | University of Chile |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 43 |
| Start date | 1 June 2023 |
| Primary completion | 10 January 2025 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across Chile |
Conditions studied
- Periodontitis — all drugs for Periodontitis →
- Peri-implantitis — all drugs for Peri-implantitis →
Sponsor
University of Chile
Who can join
18 and older, any sex, with Periodontitis or Peri-implantitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07055256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Periodontitis
Currently open trials in the same condition.
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07535177 — Gas6 and Soluble MerTK in Periodontal Diseases · recruiting
- NCT07491848 — Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D · recruiting
- NCT07421960 — Investigation of the Relationship Between Periodontitis and Sleep Quality · recruiting
- NCT07532694 — Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients · NA · recruiting
Other University of Chile trials
Trials by the same sponsor.
- NCT07372417 — Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging · not yet recruiting
- NCT07254975 — An Observational Prospective Study of Anesthetic Sensitivity Assessed by Alpha Band Power and Its Association With Emerg · not yet recruiting
- NCT06028854 — Blood Characteristics and Abdominal Emergency Surgery · suspended
- NCT07585669 — Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease · NA · recruiting
- NCT07152171 — Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07055256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Chile
- Last refreshed: 8 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07055256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing