RecruitingNot ApplicableNCT06567535

Treatment of Mandibular Bone Cyst by Navigation and Endoscopy

A Single-arm, Single-center Clinical Study of Endoscopic Combined With Intraoperative Navigation-assisted Treatment of Giant Mandibular Cysts


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

122 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this study, with the assistance of endoscopic technology and intraoperative navigation technology, the removal and curettage of large odontogenic jaw cyst occurred in the mandible were performed to reduce the rate of postoperative nerve injury. In this study, the investigators compared the efficacy of traditional extraction and curettage with endoscopic navigation assistance in the treatment of giant mandibular bone cysts. In this study, the rate of inferior alveolar nerve injury 1 month after surgery was taken as the main outcome index, and the recurrence rate 1 year after surgery was taken as the secondary outcome index, to explore whether endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cyst could achieve lower postoperative nerve injury rate and postoperative recurrence rate.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • They are between 18 and 75 years old
  • Imaging and puncture pathology showed odontogenic cystic lesion of the mandible
  • Cystic lesions greater than or equal to 2cm in diameter and spread to the inferior alveolar nerve
  • New or recurrent cyst lesions, or odontogenic cystic lesions that are still greater than or equal to 2cm after other treatment such as fenestration and affecting the lower alveolar nerve
  • No serious systemic disease, tolerant of general anesthesia
  • Patients undergoing surgical treatment for mandibular bone cysts under general anesthesia
  • There was no inferior alveolar nerve injury before operation
  • Have not participated in other clinical trials within 30 days
  • Patients who volunteer to participate in the program and sign informed consent

Exclusion Criteria3

  • The patient has severe systemic disease or pregnancy, and is judged to be unable to tolerate the course of this clinical study and cannot tolerate general anesthesia after evaluation by the research team and multidisciplinary consultation
  • Inability to complete the entire clinical research process due to personal, social, and economic reasons
  • Patients with psychiatric disorders or inability to perceive and communicate normally, such as schizophrenia, claustrophobia, etc., are unable to complete the examination and cooperate in the entire clinical research process

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Interventions

PROCEDURENavigation and endoscopy

The model was reconstructed using patient CT data, and intraoperative surgery was performed using endoscopy and navigation.


Locations(1)

WangYan

Guangzhou, Guangdong, China

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NCT06567535


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