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.

Yixuan Li, Wenying Wang, Yihan Shen, Feng Wang, Baoxin Tao, Yiqun Wu

Abstract readClinical Trial Protocol

In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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6 authors.

Yixuan Li *Department of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology, Shanghai, China.

Wenying Wang *Department of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology, Shanghai, China.

Yihan ShenDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology, Shanghai, China.

Feng WangDivision of Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, 2B95, 2/F, OMFS, The Prince Philip Dental Hospital, 34 Hospital Rd, Sai Ying Pun, Hong Kong, China.

Baoxin TaoDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology, Shanghai, China. baoxin_tao@foxmail.com.

Yiqun WuDepartment of Second Dental Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology; Shanghai Research Institute of Stomatology, Shanghai, China. yiqunwu@hotmail.com.ORCID http://orcid.org/0000-0002-8352-6256

Funding

National Clinical Research Center for Oral Diseases NCRCO 202306

6 · The paper itself

Abstract

backgroundZygomatic 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.

methodsThis 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 registrationName 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.

Indexed as

Dental Implantation, EndosseousDental ImplantsSurgery, Computer-AssistedZygomaAdultBone PlatesBone ScrewsChinaEquivalence Trials as TopicFemaleHumansMaleMinimally Invasive Surgical ProceduresProspective StudiesRandomized Controlled Trials as TopicTime FactorsDental ImplantsDigital dentistryDynamic navigationNovel registration plateRandomized controlled trial (RCT)Zygomatic implant (ZI) surgery

Identifiers

PMID41808189

DOI10.1186/s13063-026-09609-3

PMCPMC13088797

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.