Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial
Introduction 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...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
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| author | Bing Han Xiaoyan Wang Li Peng Yuhan Wang Chunyan Zheng Zuhua Wang Yuchun Sun |
| author_facet | Bing Han Xiaoyan Wang Li Peng Yuhan Wang Chunyan Zheng Zuhua Wang Yuchun Sun |
| author_sort | Bing Han |
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| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ChiCTR2200059389. |
| format | Article |
| id | doaj-art-cb81f89730e343e2849137575f7a3fe8 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
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| series | BMJ Open |
| spelling | doaj-art-cb81f89730e343e2849137575f7a3fe82025-08-20T02:14:03ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-064901Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trialBing Han0Xiaoyan Wang1Li Peng2Yuhan Wang3Chunyan Zheng4Zuhua Wang5Yuchun Sun6Department 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, ChinaDepartment of Gastroenterology, Central South University Third Xiangya Hospital, Changsha, Hunan, China2Palleon Pharmaceuticals, Waltham, MA, USA1 Department of Neurosurgery, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, ChinaDepartment 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, ChinaDepartment 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, ChinaCenter of Digital Dentistry, Department of Prosthodontics, 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, ChinaIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ChiCTR2200059389.https://bmjopen.bmj.com/content/12/12/e064901.full |
| spellingShingle | Bing Han Xiaoyan Wang Li Peng Yuhan Wang Chunyan Zheng Zuhua Wang Yuchun Sun Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial BMJ Open |
| title | Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial |
| title_full | Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial |
| title_fullStr | Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial |
| title_full_unstemmed | Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial |
| title_short | Evaluation of a dynamic navigation system for endodontic microsurgery: study protocol for a randomised controlled trial |
| title_sort | evaluation of a dynamic navigation system for endodontic microsurgery study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/12/e064901.full |
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