Computer-assisted jaw reconstruction using 3D-printed patient-specific surgical plates versus conventional surgical plates: A randomised controlled trial

Professor Su, Yuxiong   (Principal Investigator (PI))

Dr Choi Winnie Wing Shan   (Co-Investigator)

Dr Kwok Ka Wai   (Co-Investigator)

Professor Wong May Chun Mei   (Co-Investigator)

Dr Yang Weifa   (Co-Investigator)

Dr Pu Jingya   (Co-Investigator)

40

2021-07-28

985008

Computer-assisted jaw reconstruction using 3D-printed patient-specific surgical plates versus conventional surgical plates: A randomised controlled trial

maxillofacial surgery, patient-specific, three-dimensional printing, virtual surgical planning

Others - Medicine, Dentistry and Health

08192096

Health and Medical Research Fund - Full Grant

2020

On-going

Objectives: Three-dimensional (3D)-printed patient-specific titanium plates is emerging as a new frontier in the surgical field. The aim of this randomised controlled trial is to evaluate the surgical accuracy and efficiency of computer-assisted jaw reconstruction using 3D-printed patient-specific titanium surgical plates versus conventional plates. Hypothesis to be tested: We hypothesize that compared to conventional surgical plates, computer assisted jaw reconstruction using 3D-printed patient-specific surgical plates will have improved surgical accuracy and efficiency . Design and subjects: This is an open-label, prospective, double-arm, single-centre randomised controlled clinical trial. Patients with maxillary or mandibular neoplastic, inflammatory, and congenital diseases requiring immediate or secondary jaw reconstructive surgery will be recruited in this study. Study instruments: Computer-assisted jaw reconstruction using 3D-printed patient-specific titanium surgical plates or conventional plates. Main Outcome Measures: The primary endpoint is the accuracy of reconstruction. The secondary endpoints include the reconstruction time, total operative time, intra-operative blood loss, length of post-operative hospital stay, and post-operative adverse events. Data analysis: Accuracy parameters, reconstruction time, total operative time, intra-operative blood loss, and length of post-operative hospital stay will be presented as mean with standard deviation or median values with interquartile ranges. The post-operative adverse events will be presented as frequency with standard deviation. Expected results: This randomised controlled trial will demonstrate that computer-assisted jaw reconstruction using 3D-printed patient-specific titanium surgical plates has increased accuracy and efficiency. The high-quality clinical evidence will support the mainstream use of 3D medical printing technology, which will lead to a paradigm shift in clinical practice.