Fang Shuobo, Dong Zhengjie, Zhang Wei, Chen Tong, Lv Wanqi, Zhang Chenyang, Chen Si, Hao Keyi
Department of Prosthodontics, Shanghai Stomatological Hospital & School of Stomatology, Fudan University, Shanghai, China.
Shanghai Key Laboratory of Craniomaxillofacial Development and Diseases, Fudan University, Shanghai, China.
BMJ Open. 2025 Jan 4;15(1):e090302. doi: 10.1136/bmjopen-2024-090302.
Soft-tissue defect is commonly seen in immediate maxillary posterior implantation because of tooth extraction wound and tension from bone graft. Bone graft materials exposure has a significant detrimental influence on bone augmentation. However, previous studies lack sufficient evidence to guide wound closure after immediate posterior implantation. This study aims to use 3D integration technology to evaluate the effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap (RPPCTF) on the soft-tissue closure after the immediate maxillary posterior implantation.
This is a single-centre, evaluator-blinded, randomised, two-arm parallel-group controlled trial. A total of 54 patients requiring immediate implant placement in the first upper molar extraction sockets will be recruited. The patients will be randomly assigned to two groups: one group will receive the porcine collagen matrix and the other group will receive RPPCTF on the soft-tissue closure after the immediate posterior implantation. The primary outcome is the soft-tissue volume change. Secondary outcomes include width of keratinised gingiva, healing status of soft tissue, marginal bone level and operation time.
The study protocol has been approved by the Ethics Committee of Shanghai Stomatological Hospital (SHSHIRB-2022016). The project has been registered on the ClinicalTrials.gov website and National Medical Research Registration and Filing Information System. Written informed consent was obtained from all the participants. The results of this study will be reported in a peer-reviewed journal.
ChiCTR2300067770.
由于拔牙创口和骨移植张力，软组织缺损在上颌后牙即刻种植中较为常见。骨移植材料暴露对骨增量有显著的不利影响。然而，以往的研究缺乏足够的证据来指导上颌后牙即刻种植后的创口闭合。本研究旨在使用三维整合技术评估猪胶原基质与旋转带蒂腭部结缔组织瓣（RPPCTF）对上颌后牙即刻种植后软组织闭合的效果。
这是一项单中心、评估者盲法、随机、双臂平行组对照试验。总共将招募54例需要在上颌第一磨牙拔牙窝即刻植入种植体的患者。患者将被随机分为两组：一组在即刻种植后软组织闭合时接受猪胶原基质，另一组接受RPPCTF。主要结局是软组织体积变化。次要结局包括角化龈宽度、软组织愈合状态、边缘骨水平和手术时间。
本研究方案已获得上海市口腔医院伦理委员会批准（SHSHIRB - 2022016）。该项目已在ClinicalTrials.gov网站和国家医学研究登记备案信息系统注册。所有参与者均获得书面知情同意。本研究结果将在同行评审期刊上发表。
ChiCTR2300067770。
