Robot-assisted placement of zygomatic implants without flaps
Flapless Zygomatic Implants Robot-assisted Placement
This study is testing a new robot-assisted method for placing zygomatic implants in people with significant bone loss in their upper jaw to see if it makes the process safer and more accurate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05565157 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new robotic-assisted technique for the placement of zygomatic implants in patients with severe maxillary bone resorption. The study aims to improve the accuracy and safety of implant placement by utilizing the ROSA robot to guide the drilling process, while the actual implant placement will be performed manually by a surgeon. Pre-operative planning will be conducted using a scanner to ensure optimal positioning of the implants, which is crucial for successful prosthetic outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with maxillary edentulism and severe bone resorption or those who have undergone maxillary reconstruction.
Not a fit: Patients with chronic sinusitis or those who refuse robot-guided surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more precise zygomatic implant placements, improving patient outcomes and reducing complications.
How similar studies have performed: While robotic assistance in surgery is gaining traction, this specific approach for zygomatic implants is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Having signed the informed consent Exclusion Criteria: * Patients suffering from chronic sinusitis * Patients refusing ROSA robot-guided surgery (unsigned informed consent). * Pregnant and nursing women
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Sylvie TESTELIN, Pr
- Email: sylvie.testelin@chu-amiens.fr
- Phone: 03.22.08.90.50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.