Department of Cariology and Endodontology, Peking University School and Hospital of Stomatology, National Engineering Laboratory for Digital and Material Technology of Stomatology, Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health, Beijing Key Laboratory of Digital Stomatology, National Clinical Research Center for Oral Diseases, Beijing, China.
Department of General Dentistry Ⅱ, Peking University School and Hospital of Stomatology, National Engineering Laboratory for Digital and Material Technology of Stomatology, Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health, Beijing Key Laboratory of Digital Stomatology, National Clinical Research Center for Oral Diseases, Beijing, China.
BMJ Open. 2022 Dec 13;12(12):e064901. doi: 10.1136/bmjopen-2022-064901.
Endodontic microsurgery is a very important technique for preserving the natural teeth. The outcomes of endodontic microsurgery largely depend on the skill and experience of the operators, especially for cases in which the apices are located far away from the labial/buccal cortical bone. A dynamic navigation system (DNS) could provide a more accurate and efficient way to carry out endodontic microsurgery. This study is devoted to comparing the clinical outcomes of the DNS technique with those of the freehand technique.
Sixteen patients will be randomly assigned to one of two groups. For the experimental group, the osteotomy and root-end resection will be performed under the guidance of dynamic navigation. For the control group, these procedures will be performed freehand by an endodontist. The required time to perform these procedures will be used to evaluate the efficiency of the DNS technique. A Visual Analogue Scale will be used to evaluate pain at 1, 3 and 7 days after endodontic microsurgery. Preoperative and postoperative cone beam CT scans will be obtained to evaluate the accuracy of the DNS technique. The global coronal deviations, the apical deviations and the angular deflection will be measured. The root-end resection length deviation, the root-end resection angle deviations, the extent of the osteotomy and the volume change of the buccal cortical bone will also be measured. Periapical radiographs will be obtained to evaluate the outcome at 1 year after microsurgery. The time to execute the study, including follow-ups, will last from 1 June 2022 to 31 December 2025.
The present study has received approval from the Ethics Committee of Peking University School and Hospital of Stomatology. The results will be disseminated through scientific journals.
ChiCTR2200059389.
牙髓显微外科是保存天然牙齿的一项非常重要的技术。牙髓显微外科的结果在很大程度上取决于操作人员的技能和经验，尤其是对于根尖远离唇/颊侧皮质骨的病例。动态导航系统（DNS）可以提供一种更准确、更有效的方法来进行牙髓显微外科手术。本研究旨在比较 DNS 技术与徒手技术的临床效果。
将 16 名患者随机分为两组。实验组的骨切开术和根尖切除术将在动态导航的指导下进行。对照组则由牙髓医生徒手进行这些操作。将使用完成这些操作所需的时间来评估 DNS 技术的效率。术后 1、3、7 天使用视觉模拟量表（VAS）评估疼痛程度。术前和术后的锥形束 CT 扫描将用于评估 DNS 技术的准确性。将测量全局冠向偏差、根尖向偏差和角度偏差。还将测量根尖切除长度偏差、根尖切除角度偏差、骨切开范围和颊侧皮质骨体积变化。术后 1 年将获得根尖周射线照片以评估手术效果。包括随访在内的研究执行时间将从 2022 年 6 月 1 日持续到 2025 年 12 月 31 日。
本研究已获得北京大学口腔医学院和医院伦理委员会的批准。结果将通过科学期刊传播。
ChiCTR2200059389。
