Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567535
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Treatment of Mandibular Bone Cyst by Navigation and Endoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Single-center Clinical Study of Endoscopic Combined With Intraoperative Navigation-assisted Treatment of Giant Mandibular Cysts
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 α0025 unilateral and Power80 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 150 software and 122 subjects were included considering the 10 shedding rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None