Treatment of Mandibular Bone Cyst by Navigation and Endoscopy

August 20, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study hypothesized that endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts was more effective than the traditional surgical method of removal and curettage. In this study, a prospective, single-arm, Phase II clinical study was used to design the protocol, and the estimated rate of postoperative nerve injury was reduced by about 12% from 32% to 20% compared with traditional surgery. This study started from the recruitment of subjects, oral panoramic film, maxillofacial CT and other imaging examinations were performed to confirm the diagnosis. After preliminary screening according to the inclusion and exclusion criteria, patients were enrolled after signing the informed consent letter. Endoscopic and navigational techniques were used for surgical treatment. This study referred to the prospective study of Abdullah Hanfesh et al. to evaluate the function of the inferior alveolar nerve: the bilateral mandibular and lower lip were divided into four areas: area A, area B, area C, and area D. The four areas will be lightly touched, acupuncture, cold and hot stimulation, and two-point discrimination detection four times respectively, and the detection situation of each area will be recorded. Inferior alveolar nerve function was detected before and 1 month after surgery. Light touch detection 4 points, acupuncture detection 1 point, hot and cold stimulation 1 point, two-point discrimination detection 5 points showed no nerve damage. Any other score for any of the above is considered to be nerve damage. The main study measure: postoperative nerve injury rate was calculated until the last subject was followed up. The main efficacy index of this study was the postoperative nerve injury rate of endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts. The hypothesis of this study is that the postoperative nerve injury rate of endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular cyst is lower than that of traditional excision and curettage. Study parameters were set as follows: α=0.025 (unilateral) and Power=80%. According to the results of previous studies or pre-tests, the postoperative nerve injury rate of the endoscopic navigation group was reduced by about 20% to 12%. 109 cases were calculated using PASS 15.0 software, and 122 subjects were included considering the 10% shedding rate.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. They are between 18 and 75 years old
  2. Imaging and puncture pathology showed odontogenic cystic lesion of the mandible
  3. Cystic lesions greater than or equal to 2cm in diameter and spread to the inferior alveolar nerve
  4. 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
  5. No serious systemic disease, tolerant of general anesthesia
  6. Patients undergoing surgical treatment for mandibular bone cysts under general anesthesia
  7. There was no inferior alveolar nerve injury before operation
  8. Have not participated in other clinical trials within 30 days
  9. Patients who volunteer to participate in the program and sign informed consent

Exclusion Criteria:

  1. 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
  2. Inability to complete the entire clinical research process due to personal, social, and economic reasons
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Navigation and endoscopy
The model was reconstructed using patient CT data, and intraoperative surgery was performed using endoscopy and navigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of inferior alveolar nerve injury at one month postoperatively
Time Frame: one month
Rate of inferior alveolar nerve injury at one month postoperatively
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate one year after surgery
Time Frame: one year
Recurrence rate one year after surgery
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yan Wang, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2024

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-261-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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