Treatment of Mandibular Bone Cyst by Navigation and Endoscopy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Rate of inferior alveolar nerve injury at one month postoperatively [Срок оценки: one month]

Вторичные конечные точки (1)

• Recurrence rate one year after surgery [Срок оценки: one year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• WangYan — Гуанчжоу

Публикации

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• 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

Идентификаторы

NCT: NCT06567535 · SYSKY-2024-261-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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