NCT06418945

Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery

Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (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

Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery.

Conditions

• Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tinidazole oral microneedle patch	Ultrasonic teeth cleaning: After gargling with compound chlorhexidine gargle or 3% hydrogen peroxide gargle for 1 minute, the teeth were cleaned by ultrasonic wave. After the teeth were cleaned, the wound was rinsed with 3% hydrogen peroxide to stop bleeding. Immediately after the ultrasonic cleaning, two pieces of tinidazole oral composite microneedle patch were applied to the upper and lower gums close to the inside of the first molar, especially on the tooth loss or damage, and the mouth was kept closed for 15 minutes. After the microneedle was fully degraded, the room could be left.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-05-17
• Last updated: 2024-05-17