Accuracy of Immediate Implant Placement Using Robotic System Versus Dynamic Navigation System in Anterior Maxillae: A Random Controlled Clinical Trial
1 other identifier
interventional
24
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
1 active site
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
First Submitted
Initial submission to the registry
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
May 22, 2026
May 1, 2026
3 months
March 20, 2025
May 19, 2026
Conditions
Keywords
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. (Global deviation at platform and apex, Angular deviation)
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
EXPERIMENTALImmediate implant placement assisted by robotic surgery
Dynamic navigation
SHAM COMPARATORImmediate implant placement assisted by dynamic navigation
Interventions
immediate implant placement assisted by dynamic navigation
Eligibility Criteria
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 intact; 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
Study Sites (1)
Shanghai Ninth People's Hospital, Department of oral implantology
Shanghai, Shanghai Municipality, 200011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- 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
June 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- start date: 2026.12 end date: 2027.12
- Access Criteria
- De-identified individual participant data and supporting study documents (including the study protocol and statistical analysis plan) will be available to qualified researchers upon reasonable request to the corresponding author after publication of the study results. Access will be granted for scientifically sound research purposes following review and approval of the research proposal. Data will be shared through secure electronic transfer.
Individual participant data that underlie the results reported in this article, after de-identification, will be shared upon reasonable request to the corresponding author following publication.