Treatment of Mandibular Bone Cyst by Navigation and Endoscopy

NCT06567535 | Recruiting DMC

• 1 other identifier: SYSKY-2024-261-03
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Jaw Cysts

Outcome Measures

Primary Outcomes (1)

• Rate of inferior alveolar nerve injury at one month postoperatively

  Rate of inferior alveolar nerve injury at one month postoperatively

  one month

Secondary Outcomes (1)

• Recurrence rate one year after surgery

  one year

Study Arms (1)

Navigation and endoscopy Group

EXPERIMENTAL

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

Interventions

Navigation and endoscopy PROCEDURE

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

Navigation and endoscopy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

WangYan

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (15)

• Rajendra Santosh AB. Odontogenic Cysts. Dent Clin North Am. 2020 Jan;64(1):105-119. doi: 10.1016/j.cden.2019.08.002. Epub 2019 Oct 18.

  PMID: 31735221 RESULT

• Manor E, Kachko L, Puterman MB, Szabo G, Bodner L. Cystic lesions of the jaws - a clinicopathological study of 322 cases and review of the literature. Int J Med Sci. 2012;9(1):20-6. doi: 10.7150/ijms.9.20. Epub 2011 Nov 9.

  PMID: 22211085 RESULT

• Anavi Y, Gal G, Miron H, Calderon S, Allon DM. Decompression of odontogenic cystic lesions: clinical long-term study of 73 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Aug;112(2):164-9. doi: 10.1016/j.tripleo.2010.09.069. Epub 2010 Dec 30.

  PMID: 21194990 RESULT

• Marin S, Kirnbauer B, Rugani P, Mellacher A, Payer M, Jakse N. The effectiveness of decompression as initial treatment for jaw cysts: A 10-year retrospective study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e47-e52. doi: 10.4317/medoral.22526.

  PMID: 30573706 RESULT

• Wang Y, Chang S, Lin Z, Chen R, Huang Z. Endoscopic-assisted enucleation of large mandibular odontogenic cysts. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Feb;129(2):115-119. doi: 10.1016/j.oooo.2019.05.012. Epub 2019 Jun 6.

  PMID: 31786170 RESULT

• Tamiolakis P, Thermos G, Tosios KI, Sklavounou-Andrikopoulou A. Demographic and Clinical Characteristics of 5294 Jaw Cysts: A Retrospective Study of 38 Years. Head Neck Pathol. 2019 Dec;13(4):587-596. doi: 10.1007/s12105-019-01011-7. Epub 2019 Feb 13.

  PMID: 30758760 RESULT

• Wakolbinger R, Beck-Mannagetta J. Long-term results after treatment of extensive odontogenic cysts of the jaws: a review. Clin Oral Investig. 2016 Jan;20(1):15-22. doi: 10.1007/s00784-015-1552-y. Epub 2015 Aug 8.

  PMID: 26250795 RESULT

• Gao Z, Ni QW, Gao W, Liu YP, Zhang Q. Application of endoscopy to treat mandibular keratocystic odontogenic tumors. Braz J Med Biol Res. 2017 Jul 10;50(8):e6209. doi: 10.1590/1414-431X20176209.

  PMID: 28700034 RESULT

• Sembronio S, Albiero AM, Zerman N, Costa F, Politi M. Endoscopically assisted enucleation and curettage of large mandibular odontogenic keratocyst. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):193-6. doi: 10.1016/j.tripleo.2008.07.020. Epub 2008 Sep 17.

  PMID: 18801672 RESULT

• Huang Z, Huang Z, Zhang D, Hu H, Liang Q, Chen W. Endoscopically-assisted operations in the treatment of odontogenic peripheral osteomyelitis of the posterior mandible. Br J Oral Maxillofac Surg. 2016 Jun;54(5):542-6. doi: 10.1016/j.bjoms.2016.02.023. Epub 2016 Mar 26.

  PMID: 27025231 RESULT

• Azarmehr I, Stokbro K, Bell RB, Thygesen T. Surgical Navigation: A Systematic Review of Indications, Treatments, and Outcomes in Oral and Maxillofacial Surgery. J Oral Maxillofac Surg. 2017 Sep;75(9):1987-2005. doi: 10.1016/j.joms.2017.01.004. Epub 2017 Jan 18.

  PMID: 28193444 RESULT

• Sukegawa S, Kanno T, Furuki Y. Application of computer-assisted navigation systems in oral and maxillofacial surgery. Jpn Dent Sci Rev. 2018 Aug;54(3):139-149. doi: 10.1016/j.jdsr.2018.03.005. Epub 2018 May 7.

  PMID: 30128061 RESULT

• de Geer AF, Brouwer de Koning SG, van Alphen MJA, van der Mierden S, Zuur CL, van Leeuwen FWB, Loeve AJ, van Veen RLP, Karakullukcu MB. Registration methods for surgical navigation of the mandible: a systematic review. Int J Oral Maxillofac Surg. 2022 Oct;51(10):1318-1329. doi: 10.1016/j.ijom.2022.01.017. Epub 2022 Feb 11.

  PMID: 35165005 RESULT

• Sozzi D, Filippi A, Canzi G, De Ponti E, Bozzetti A, Novelli G. Surgical Navigation in Mandibular Reconstruction: Accuracy Evaluation of an Innovative Protocol. J Clin Med. 2022 Apr 6;11(7):2060. doi: 10.3390/jcm11072060.

  PMID: 35407667 RESULT

• Hanfesh A, Salma RG, Al Mutairi K, AlShiha SK, Al Otaibi S. The neurosensory deficit of inferior alveolar nerve following bilateral sagittal split osteotomy: a prospective study. Oral Maxillofac Surg. 2022 Sep;26(3):401-415. doi: 10.1007/s10006-021-01005-2. Epub 2021 Sep 12.

  PMID: 34510239 RESULT

MeSH Terms

Conditions

Jaw Cysts

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yan Wang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang

CONTACT

13825119105; wangy573@mail.sysu.edu.cn

YILIN HE

CONTACT

13680281880; 839506041@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 22, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)