NCT06895915

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 20, 2025

Last Update Submit

March 20, 2025

Conditions

Tooth Diseases

Keywords

immediate implant placementdynamic navigationrobotic surgery

Outcome Measures

Primary Outcomes (1)

  • Implant positional accuracy

    Implant accuracy will be measured as discrepancy between the digital plan and the actual position of the implant.

    immediately after surgery

Secondary Outcomes (5)

  • Surgery time

    intraoperative

  • Pain perception

    Immediately after surgery

  • Pain perception

    7 days after surgery

  • Surgeon preference

    Immediately after surgery

  • Soft tissue changes

    immediately after crown delivery

Study Arms (2)

Robotic Surgery

EXPERIMENTAL

Immediate implant placement assisted by robotic surgery

Procedure: dynamic navigation surgery

Dynamic navigation

SHAM COMPARATOR

Immediate implant placement assisted by dynamic navigation

Procedure: robotic surgery

Interventions

dynamic navigation surgeryPROCEDURE

immediate implant placement assisted by dynamic navigation

Robotic Surgery
robotic surgeryPROCEDURE

immediate implant placement assisted by robotic surgery

Dynamic navigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Diseases

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Central Study Contacts

Yijie Zhang, Master

CONTACT

13524325673izhangyijie@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

April 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03