Flapless Zygomatic Implants Robot-assisted Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.
However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.
This approach is technically difficult, and is performed by an experienced surgeon.
The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.
Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 old
Disqualifiers
Patients suffering from chronic sinusitis
Patients refusing ROSA robot-guided surgery (unsigned informed consent).
Pregnant and nursing women
Trial design
Design model
Single group
Treatments tested in this trial
Zygomatic implants
Procedure/SurgeryA robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Variation rate between theoretical intraoperative position and post-operative zygomatic implants position
The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.
Time frame
one daySponsors and contacts
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Source ClinicalTrials.gov