The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery
1 other identifier
interventional
28
1 country
1
Brief Summary
We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.
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 Oct 2023
Shorter than P25 for not_applicable
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
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
October 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2023
CompletedSeptember 28, 2023
September 1, 2023
1 month
September 22, 2023
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant positional accuracy
Implant accuracy will be measured as distance discrepancy at implant platform and implant apex, and angular discrepancy of implant axis between the digital plan and the actual position of the implant assessed digitally at the end of the procedure. Pre- and post-operative CBCT will be used for measurement.
immediately after surgery
Secondary Outcomes (1)
Surgery complication
Immediately and seven days after surgery
Study Arms (2)
Robot-guided
EXPERIMENTALImplant placement by robot-guided based on a digital plan
Freehand surgery
ACTIVE COMPARATORImplant placement by freehand based on a digital plan
Interventions
Implant placement will be navigated by a dental implant robot based on a digital plan.
Eligibility Criteria
You may qualify if:
- Single missing teeth with adjacent and opposing healthy natural teeth;
- Healthy patients;
- Sufficient alveolar bone available for implant placement.
You may not qualify if:
- Pregnancy or intention to become pregnant at any point during the study duration
- With any systemic diseases/conditions that are contraindications to dental implant...
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qi Yanlead
Study Sites (1)
School & Hospital of Stomatology, Wuhan University
Wuhan, Hubei, 430070, China
Study Officials
- PRINCIPAL INVESTIGATOR
Qi Yan, PhD
School & Hospital of Stomatology, Wuhan University
- STUDY CHAIR
Yufeng Zhang, PhD
School & Hospital of Stomatology, Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
September 22, 2023
First Posted
September 28, 2023
Study Start
October 7, 2023
Primary Completion
November 7, 2023
Study Completion
December 7, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share