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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
WangYan
RECRUITING
Guangzhou
Contact Information
Primary
Yan Wang
wangy573@mail.sysu.edu.cn
13825119105
Backup
YILIN HE
839506041@qq.com
13680281880
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 122
Treatments
Experimental: Navigation and endoscopy Group
Preoperative copies of the patient's maxillofacial imaging data were digitally designed, professional software was used to segment cystic lesions and segment the inferior alveolar nerve together, and then the data was imported into the navigation system. The surgeon placed a mandibular reference frame in the anterior mandibular region, and used the navigation probe to accurately locate the difficult areas such as the anterior part of the capsule cavity, the apical part of the tooth root and the ascending branch of the mandible under the guidance of navigation. After accurate positioning was obtained, the navigation adapter was loaded onto the endoscope to locate the lesions in all directions and the inferior alveolar nerve under visual conditions, and further precisely curettage the lesions in the cystic cavity with the assistance of the adapter.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov