Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology

The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site. Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality \[MR\] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.

NCT Number	NCT07466810
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions	Tongue Squamous Cell Carcinoma, Mixed Reality, Virtual Surgical Planning, Free Flap, Oral Cancer
Enrollment	30 participants
Start Date	2026-04-01
Primary Completion	2027-04-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-20