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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings