Actively Recruiting
Flapless Zygomatic Implants Robot-assisted Placement
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-07-10
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new robotic-assisted surgical technique for placing zygomatic implants in patients with severe bone loss in the upper jaw (maxilla). This study focuses on improving the accuracy and safety of positioning these implants, which are challenging to place correctly and require experienced surgeons. The trial aims to assess how well the robot-guided method matches the planned implant position. The procedure involves planning the implant placement using a pre-operative scan. The ROSA robot will assist by guiding several drilling steps, while the actual placement of the zygomatic implants will be done manually by the surgeon. This flapless approach is designed to be less invasive and more precise than traditional methods. Participants will undergo assessments comparing the planned implant position with the actual post-operative position measured one day after surgery. The study tracks the variation rate between these positions to evaluate accuracy. The involvement includes robotic guidance during surgery and post-operative evaluation to monitor the implant placement precision and safety.
CONDITIONS
Brief Title
Flapless Zygomatic Implants Robot-assisted Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suffering from maxillary edentulism with severe bone resorption
- Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction
- Patients suffering from post-maxillectomy buccosinusal communication
- Age 18 years or older
- Having signed the informed consent
You will not qualify if you...
- Patients suffering from chronic sinusitis
- Patients refusing ROSA robot-guided surgery (unsigned informed consent)
- Pregnant and nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo robotic assisted placement of zygomatic implants and receive immediate post-operative care.
1 surgical visit and immediate post-operative observation
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
S
Sylvie TESTELIN, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
Frequently Asked Questions
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