Comparison of the accuracy of minimally invasive registration technology and traditional registration in dynamic navigation-assisted zygomatic implant surgery in China: study protocol for a non-inferiority randomized controlled trial

BACKGROUND: Zygomatic implant (ZI) is an effective method for restoring masticatory function and mid-facial appearance in patients with severe alveolar ridge resorption, avoiding complex bone augmentation. Dynamic navigation-assisted surgery has been introduced to improve ZI placement accuracy, with registration being a crucial step. However, the current registration method using fiducial screws is limited by their concentrated placement in the mouth, reducing accuracy around the zygomatic bone. This study aims to evaluate the accuracy and clinical outcomes of a novel minimally invasive registration plate in ZI surgery, guiding its clinical application in dynamic navigation-assisted ZI surgery. METHODS: This is a prospective, single-center, parallel-group, non-inferiority randomized controlled trial conducted at Shanghai Ninth People's Hospital, Shanghai, China. We plan to recruit 20 patients who need ZI restoration. The inclusion criteria include severe atrophy of the maxillary alveolar ridge or maxillary bone defects. The anterior region must have adequate bone volume to allow placement of two temporary implants or at least four pins for registration plate fixation, or existing implants or residual teeth can provide stable fixation for the registration plate. Participants will be randomly assigned in a 1:1 allocation ratio into two groups: control group: dynamic navigation registration using traditional titanium screws; experimental group: dynamic navigation registration using the novel registration plate. The group assignment will be blinded for accuracy evaluators. Entry and exit point and angular deviations of the ZI, surgical time, registration accuracy, patient satisfaction, implant survival rate, and adverse event incidence will be assessed. DISCUSSION: A novel minimally invasive registration plate has been designed to extend the coverage of registration points to the zygomatic bone, thereby expanding the registration range for dynamic navigation-assisted zygomatic implant placement. This study aims to compare the new registration approach with the conventional titanium screw-based method to evaluate whether it enhances the accuracy of dynamic navigation-assisted zygomatic implant surgery. TRIAL REGISTRATION: Name of the registry: Chinese Clinical Trial Registry (ChiCTR). TRIAL REGISTRATION NUMBER: ChiCTR2500103641 (retrospectively registered). Date of registration: 2025-06-03. First planned enrollment: 2024-11-17. URL of trial registry record: https://www.chictr.org.cn/showproj.html?proj=272887.