Accuracy of Immediate Implant Placement Using Robotic System Versus Dynamic Navigation System in Anterior Maxillae: a Random Controlled Clinical Trial

NCT ID: NCT06895915

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-30

Brief Summary

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

Detailed Description

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. However, dynamic navigation faces the following deficiencies in immediate implant placement. Firstly, it has a steep learning curve. Secondly, the rigid palatal bone wall of the socket will force the direction of drill deviating buccally. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess the professional outcomes.

Conditions

Tooth Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotic Surgery

Immediate implant placement assisted by robotic surgery

Group Type: EXPERIMENTAL

dynamic navigation surgery

Intervention Type: PROCEDURE

immediate implant placement assisted by dynamic navigation

Dynamic navigation

Immediate implant placement assisted by dynamic navigation

Group Type: SHAM_COMPARATOR

robotic surgery

Intervention Type: PROCEDURE

immediate implant placement assisted by robotic surgery

Interventions

dynamic navigation surgery

immediate implant placement assisted by dynamic navigation

Intervention Type: PROCEDURE

robotic surgery

immediate implant placement assisted by robotic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• a. ≥18 years old and in good health; b. One or more maxillary incisors that cannot be retained due to non-periodontitis; c. The buccal bone plate is complete; d. No acute infection; e. The extraction socket have at least 3-5 mm apical bone.

Exclusion Criteria

• a. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); b. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); c. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm; d. Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day); e. Refuse to participate in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

shichong Qiao

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yijie Zhang, Master

Role: CONTACT

izhangyijie@163.com

13524325673

Other Identifiers

SH9H-2024-T306-2

Identifier Type: -

Identifier Source: org_study_id