NCT06722300

Clinical Study on the Impact of Eradication of Oral Porphyromonas Gingivalis on the Prognosis of Early Esophageal Cancer After ESD Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 856 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Porphyromonas gingivalis (Pg) is a representative pathogenic bacterium of periodontitis and is a Gram-negative anaerobic bacterium. Epidemiological studies suggest that periodontitis is positively correlated with the risk of gastrointestinal tumors such as esophageal cancer. Pg has been extensively studied due to its unique ability to invade epithelial cells and survive in host blood and tissues, and has been confirmed to be associated with esophageal cancer, pancreatic cancer, and oral cancer. Pg is enriched in esophageal cancer tissues and atypical hyperplasia lesions of esophageal mucosa, and is rarely found in corresponding non-tumor parts, cardiac cardia, and stomach. Treating normal esophageal mucosal epithelial cells with Pg medium can induce atypical hyperplasia. Chen et al found that the Pg infection rate in esophageal squamous cell carcinoma is as high as 57%. Gao S et al. used 16S rDNA PCR technology to detect 100 ESCC patients. The detection rate of Pg pan-antigen was 61% in tumor tissues, 12% in para-cancerous tissues, and was not detected in normal mucosal tissues. Studies have shown that Pg and Pg/Prevotella ratio in saliva can be used as reference indicators for the diagnosis of esophageal cancer. The abundance of Pg in saliva and dental plaque is associated with the development of esophageal squamous cell carcinoma and poor prognosis. High levels of Pg-specific antibodies in serum are an independent predictor of poor prognosis in esophageal squamous cell carcinoma. Gao et al.'s study found that Pg infection is closely related to local recurrence after endoscopic resection. Studies based on ESCC patients data, animal models and esophageal squamous cell carcinoma cell lines have confirmed that Pg promotes the occurrence and development of esophageal cancer, leads to resistance to neoadjuvant chemotherapy, and weakens the efficacy of anti-tumor treatment. In summary, whether the recurrence of early esophageal cancer after ESD can be controlled by removing Pg deserves further exploration. To this end, based on the combined treatment of mechanical removal and antibacterial drugs, this study designed a method that combines ultrasonic tooth cleaning with tinidazole oral composite microneedle patches to completely remove oral Pg and evaluate the impact on the prognosis of early ESCC after ESD therapy by extra removal of oral Porphyromonas gingivalis.

Detailed description

The new oral microneedle patch was developed by the Oncology Molecular Biology Laboratory of the First Affiliated Hospital of Henan University of Science and Technology. The patch consists of a dissolvable basement membrane part and a needle tip loaded with drugs and polylactic acid-co-glycolic acid microspheres. The base film of the new oral microneedle patch is made of 10% gelatin. 10% gelatin can solidify at room temperature and dissolve in a few minutes at body temperature. Antibiotics can be loaded directly into the gelatin-based membrane and released rapidly. The tip part is made of gelatin methacryloyl (GelMA) cross-linked by UV light. GelMA forms a hydrogel structure that gradually degrades and can be used as a carrier for sustained drug release. After applying the oral microneedle patch, the basement membrane quickly dissolves and releases the tinide file, which can effectively reduce the content of harmful bacteria in the oral cavity. The needle tip structure composed of GelMA can penetrate and stay in the gingival tissue, continuously releasing tinide files and cytokines to promote the repair of gingival tissue.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	Ultrasonic teeth cleaning plus Tinidazole microneedle patches applying	After gargling with compound chlorhexidine rinse or 3% hydrogen peroxide rinse for 1 minute, ultrasonic teeth cleaning was performed. After teeth cleaning, the wound was rinsed with 3% hydrogen peroxide and bleeding was stopped. After ultrasonic teeth cleaning, two metronidazole oral composite microneedle patches were immediately applied to the upper and lower gums near the inner side of the first molar, especially where the teeth were lost or damaged. The mouth was kept closed for 15 minutes. After the microneedles were fully degraded, the patient could leave the clinic.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-05-01
• Completion: 2029-12-31
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: China